Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-04 @ 11:23 PM
Study NCT ID:
NCT02006069
Status:
TERMINATED
Last Update Posted:
2023-05-17
First Post:
2013-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Africa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'C535598', 'term': 'Creatine deficiency, X-linked'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kwangdeok.lee@abbott.com', 'phone': '+19725269673', 'title': 'Kwangdeok Lee PhD', 'organization': 'Abbott'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months to 12 months after randomization', 'eventGroups': [{'id': 'EG000', 'title': 'MPP ON', 'description': 'MPP ON: feature is enabled after 6 months\n\nMPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 67, 'seriousNumAtRisk': 271, 'deathsNumAffected': 4, 'seriousNumAffected': 82}, {'id': 'EG001', 'title': 'BIVP', 'description': 'MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.', 'otherNumAtRisk': 555, 'deathsNumAtRisk': 555, 'otherNumAffected': 118, 'seriousNumAtRisk': 555, 'deathsNumAffected': 18, 'seriousNumAffected': 190}], 'otherEvents': [{'term': 'Atrial or Ventricular Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 43, 'numAffected': 41}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacemaker Mediated Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperthyreosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Diverticulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain at Pulse Generator Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Worsening of General Patient's Condition", 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Sinus Dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bodily Rejection Phenomena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Pacing Thresholds/Loss of Capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lead Dislodgement or Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacemaker Mediated Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Therapy for Non-Ventricular Rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective Replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding/Hematoma/Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anticoagulant Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial or Ventricular Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 28, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 60, 'numAffected': 42}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiorespiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 40, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 76, 'numAffected': 53}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mitral Valve Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pacemaker Mediated Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden Cardiac Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Valve Damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperthyroidism Caused by Amiodarone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Affliction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding/Hematoma/Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Downhill Varicose and Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal Varices', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Obstipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatic Cystic Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug Side Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 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'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ureteral Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebellar Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Lead Pacing Impedance <= 200 OHMS or >=2000 OHMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated 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'numAtRisk': 555, 'numEvents': 40, 'numAffected': 36}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lead Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oversensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulse Generator Migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Therapy for Non-Ventricular Rhythm', 'stats': [{'groupId': 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'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Larynx Perforation After Tee', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudo-Nodular Lung Consolidation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nose Resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding/Hematoma/Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bypass Graft Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracardiac Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower Extremity Claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 271, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 555, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Non-responder Patients Who Converted to Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MPP ON', 'description': 'MPP ON: feature is enabled after 6 months\n\nMPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.'}, {'id': 'OG001', 'title': 'BiVP', 'description': 'MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Non-responder to responder conversion rate between randomization at 6 months and 12 months', 'description': 'The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MPP ON', 'description': 'MPP ON: feature is enabled after 6 months\n\nMPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.'}, {'id': 'OG001', 'title': 'BiVP', 'description': 'MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline vs 6 Months', 'description': 'Reduction of LVESV between baseline and 6 Months visit', 'unitOfMeasure': 'percentage of LVESV change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Composite Score Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '555', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MPP ON', 'description': 'MPP ON: feature is enabled after 6 months\n\nMPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.'}, {'id': 'OG001', 'title': 'BiVP', 'description': 'MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}, {'title': 'Unchanged', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}, {'title': 'Worsensed', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline vs 12 Months', 'description': "Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below,\n\n* Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation\n* Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation\n* Unchanged: the patient was neither improved nor worsened", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reverse Left Ventricular (LV) Remodeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MPP ON', 'description': 'MPP ON: feature is enabled after 6 months\n\nMPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.'}, {'id': 'OG001', 'title': 'BiVP', 'description': 'MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '24', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '23.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline vs 12 Months', 'description': 'Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with LVESV data available at both baseline and 12 months were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'NYHA Class Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MPP ON', 'description': 'MPP ON: feature is enabled after 6 months\n\nMPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.'}, {'id': 'OG001', 'title': 'BiVP', 'description': 'MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.'}], 'classes': [{'categories': [{'title': 'Improved', 'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}, {'title': 'Unchanged', 'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}, {'title': 'Worsened', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline vs 12 Months', 'description': 'Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with NYHA data available at both baseline and 12 months were included in this analysis.'}, {'type': 'SECONDARY', 'title': '6MWT Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '441', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MPP ON', 'description': 'MPP ON: feature is enabled after 6 months\n\nMPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.'}, {'id': 'OG001', 'title': 'BiVP', 'description': 'MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '113.6', 'groupId': 'OG000'}, {'value': '46', 'spread': '121.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline vs 12 Months', 'description': "Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU", 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with 6MHWT data available at both baseline and 12 months were included in this analysis.'}, {'type': 'SECONDARY', 'title': "Patient's QoL Score Changes (MLWHF)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MPP ON', 'description': 'MPP ON: feature is enabled after 6 months\n\nMPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.'}, {'id': 'OG001', 'title': 'BiVP', 'description': 'MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.6', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '-12.2', 'spread': '21.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline vs 12 Months', 'description': "Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with MLWHF data available at both baseline and 12 months were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MPP ON', 'description': 'MPP ON: feature is enabled after 6 months\n\nMPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.\n\nThe MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").'}, {'id': 'FG001', 'title': 'BiVP', 'description': 'MPP OFF: Continuous BiVP after 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '510'}, {'groupId': 'FG001', 'numSubjects': '558'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '555'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '239'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'MPP other programming', 'reasons': [{'groupId': 'FG000', 'numSubjects': '239'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'RV only pacing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': "The study enrolled eligible patients with a standard CRT indication after obtaining written informed consent. The implanting physician programmed biventricular pacing (BiVP) at implant in those patients who had the quadripolar CRT system successfully implanted The implanting physician programmed the LV pacing vector, A-V delay, and V-V delay settings at their discretion until the patient's randomization at 6 months.", 'preAssignmentDetails': 'For the first 6 months post-implant, all enrolled patients were followed with traditional biventricular pacing (BiVP). Only patients not responding to BiVP between baseline and 6 months (using LVESV reduction less than 15%), which is called CRT non-responders, were randomized to either MPP or continuous BiVP arm at 6 months and followed until 12 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'BG000'}, {'value': '555', 'groupId': 'BG001'}, {'value': '826', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MPP ON', 'description': 'MPP ON: feature is enabled after 6 months\n\nMPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis.'}, {'id': 'BG001', 'title': 'BiVP', 'description': 'MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'BG000'}, {'value': '555', 'groupId': 'BG001'}, {'value': '826', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.4', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '68.1', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '68.2', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'BG000'}, {'value': '555', 'groupId': 'BG001'}, {'value': '826', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '432', 'groupId': 'BG001'}, {'value': '658', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Type of Cardiomyopathy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'BG000'}, {'value': '555', 'groupId': 'BG001'}, {'value': '826', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Ischemic', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '425', 'groupId': 'BG002'}]}, {'title': 'Non-ischemic', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '277', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'NYHA Class', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'BG000'}, {'value': '555', 'groupId': 'BG001'}, {'value': '826', 'groupId': 'BG002'}]}], 'categories': [{'title': 'II', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}, {'title': 'III', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '405', 'groupId': 'BG002'}]}, {'title': 'IV', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Not done', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Class I: No limitation of physical activity Class II(Mild): Slight limitation of physical activity. Class III(Moderate): Marked limitation of physical activity. Class IV(Severe): Unable to carry out any physical activity without discomfort.\n\nIncreasing functional class is associated with greater risk of death and hospitalization.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A race/ethnicity baseline was not collected in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-09', 'size': 1082408, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-20T17:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5850}}, 'statusModule': {'whyStopped': 'The steering committee had decided to discontinue enrollment because the interim analysis showed a low probability that the study would meet the primary endpoint. The interim analysis did not demonstrate any safety concerns with activating MPP.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2013-09-23', 'resultsFirstSubmitDate': '2022-05-25', 'studyFirstSubmitQcDate': '2013-12-04', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-21', 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Non-responder Patients Who Converted to Responders', 'timeFrame': 'Non-responder to responder conversion rate between randomization at 6 months and 12 months', 'description': 'The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.'}], 'secondaryOutcomes': [{'measure': 'Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase', 'timeFrame': 'Baseline vs 6 Months', 'description': 'Reduction of LVESV between baseline and 6 Months visit'}, {'measure': 'Clinical Composite Score Evaluation', 'timeFrame': 'Baseline vs 12 Months', 'description': "Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below,\n\n* Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation\n* Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation\n* Unchanged: the patient was neither improved nor worsened"}, {'measure': 'Reverse Left Ventricular (LV) Remodeling', 'timeFrame': 'Baseline vs 12 Months', 'description': 'Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months'}, {'measure': 'NYHA Class Changes', 'timeFrame': 'Baseline vs 12 Months', 'description': 'Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.'}, {'measure': '6MWT Changes', 'timeFrame': 'Baseline vs 12 Months', 'description': "Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU"}, {'measure': "Patient's QoL Score Changes (MLWHF)", 'timeFrame': 'Baseline vs 12 Months', 'description': "Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CRT, non responders, MultiPoint Pacing (MPP)'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '30859220', 'type': 'DERIVED', 'citation': 'Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Calo L, Vicentini A, Concha JF, Thibault B. Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I. Eur Heart J. 2019 Sep 14;40(35):2979-2987. doi: 10.1093/eurheartj/ehz109.'}, {'pmid': '30616009', 'type': 'DERIVED', 'citation': 'Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Cohorn C, Thibault B; MORE-CRT MPP Investigators. Rationale and design of a randomized clinical trial to assess the safety and efficacy of multipoint pacing therapy: MOre REsponse on Cardiac Resynchronization Therapy with MultiPoint Pacing (MORE-CRT MPP-PHASE II). Am Heart J. 2019 Mar;209:1-8. doi: 10.1016/j.ahj.2018.12.004. Epub 2018 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.', 'detailedDescription': "This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)\n* Must be willing and able to comply with study requirements\n* Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form\n\nExclusion Criteria:\n\n* Already had a CRT device implanted\n* Myocardial Infarction, unstable angina within 40 days prior the enrollment\n* Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following\n* Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment\n* Primary valvular disease\n* Atrial Fibrillation:\n\n * Persistent AF at the time of enrollment\n * Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant\n * History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment\n* Unable to comply with the follow up schedule\n* Less than 18 years of age\n* Pregnant or are planning to become pregnant during the duration of the investigation\n* Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months\n* Undergone a cardiac transplantation\n* Life expectancy \\< 12 months\n* Currently participating in any other clinical investigation'}, 'identificationModule': {'nctId': 'NCT02006069', 'acronym': 'MORE CRT MPP', 'briefTitle': 'MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)', 'orgStudyIdInfo': {'id': 'CR-13-006-ID-HF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MPP ON', 'description': 'MPP ON: feature is enabled', 'interventionNames': ['Device: MPP']}, {'type': 'NO_INTERVENTION', 'label': 'MPP OFF', 'description': 'MPP OFF: feature not enabled'}], 'interventions': [{'name': 'MPP', 'type': 'DEVICE', 'description': 'All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.\n\nThe MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician\'s discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").', 'armGroupLabels': ['MPP ON']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research, LLC.', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cardiovascular Associates of Mesa', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Cardiovascular Research Group', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive 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