Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
Study NCT ID:
NCT01733368
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2012-10-02
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jalzueta@telefonica.net', 'phone': '951 03 20 00', 'title': 'Dr. Javier Alzueta Rodríguez', 'organization': 'Hospital Clinico Universitario Virgen de la Victoria'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months after CRT implant', 'eventGroups': [{'id': 'EG000', 'title': 'Quadripolar Left Ventricular Lead (Quartet Lead)', 'description': 'Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead', 'otherNumAtRisk': 198, 'deathsNumAtRisk': 198, 'otherNumAffected': 15, 'seriousNumAtRisk': 198, 'deathsNumAffected': 6, 'seriousNumAffected': 50}], 'otherEvents': [{'term': 'Upgrade of the device to DDD by adding atrial lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shiver and physical discomfort during implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding/Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 7}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'carbon dioxide narcosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary sinus dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate ATP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nause and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in the implant site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'phrenic nerve/diaphragmatic/extracardiac stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute Calculous Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial or Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding/Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest and death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbacion of Heart Failulre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbacion of Heart Failulre and Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Malignant tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infartion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhabdomyolysis due to amiodarone and statins treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Pacing Thresholds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lead Dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 10}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Phrenic Nerve/Diaphragmatic/Extracardiac stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis and Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Responder Patients (Structural Remodelling)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadripolar Left Ventricular Lead (Quartet Lead)', 'description': 'Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after implant', 'description': 'Structural remodelling is defined as a reduction \\>15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with the 6-month follow-up completed and echocardiographic measurements available'}, {'type': 'PRIMARY', 'title': 'Safety Outcomes in CRT Responders and Non-Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6-Month CRT Responder', 'description': 'Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a responder at 6 months of follow-up.'}, {'id': 'OG001', 'title': '6-Month CRT Non-Responder', 'description': 'Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a non-responder at 6 months of follow-up.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'All-cause hospitalization', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Deaths & Hospitalizations', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after implant', 'description': '* Mortality rate,\n* Rate of cardiovascular hospitalizations and for any cause or\n* Combined endpoint (death and all-cause hospitalization)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients experiencing clinical safety event prior to the 6-month follow-up visit.'}, {'type': 'SECONDARY', 'title': 'Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadripolar Left Ventricular Lead (Quartet Lead)', 'description': 'Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after implant', 'description': 'Response is defined as a reduction \\>15% in LVESV, measured 6 months after implant.\n\nNon-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with non-conventional LV pacing vector'}, {'type': 'SECONDARY', 'title': 'Number of Responder Patients With Conventional Left Ventricular Pacing Vector', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Quadripolar Left Ventricular Lead (Quartet Lead)', 'description': 'Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months after implant', 'description': 'Response is defined as a reduction \\>15% in LVESV, measured 6 months after implant.\n\nConventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with a conventional pacing vector'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Quadripolar Left Ventricular Lead (Quartet Lead)', 'description': 'Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Quadripolar Left Ventricular Lead (Quartet Lead)', 'description': 'Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.01', 'spread': '10.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '146', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association (NYHA) Classification', 'classes': [{'categories': [{'title': 'NYHA I', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'NYHA II', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}, {'title': 'NYHA III', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}, {'title': 'NYHA IV', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The NYHA Functional Classification provides a simple way of classifying the extent of heart failure:\n\nI Cardiac disease, but no symptoms and no limitation in ordinary physical activity.\n\nII Mild symptoms and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.\n\nIV Severe limitations. Experiences symptoms even while at rest.', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiovascular Etiology: Ischemic, Non-ischemic', 'classes': [{'categories': [{'title': 'Ischemic', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'Non-ischemic', 'measurements': [{'value': '118', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'QRS Duration', 'classes': [{'categories': [{'measurements': [{'value': '168', 'spread': '22.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'miliseconds (ms)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'QRS Morphology', 'classes': [{'categories': [{'title': 'Left Bundle Branch Block (LBBB)', 'measurements': [{'value': '168', 'groupId': 'BG000'}]}, {'title': 'Right Bundle Branch Block (RBBB)', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Interventricular Conduction Delay (IVCD)', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ejection Fraction (EF)', 'classes': [{'categories': [{'measurements': [{'value': '26.87', 'spread': '7.38', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage (%)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Left Ventricular End Systolic Volume (LVESV)', 'classes': [{'categories': [{'measurements': [{'value': '155.17', 'spread': '75.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milliliters (ml)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2012-10-02', 'resultsFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2012-11-20', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-26', 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Responder Patients (Structural Remodelling)', 'timeFrame': '6 months after implant', 'description': 'Structural remodelling is defined as a reduction \\>15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.'}, {'measure': 'Safety Outcomes in CRT Responders and Non-Responders', 'timeFrame': '6 months after implant', 'description': '* Mortality rate,\n* Rate of cardiovascular hospitalizations and for any cause or\n* Combined endpoint (death and all-cause hospitalization)'}], 'secondaryOutcomes': [{'measure': 'Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector', 'timeFrame': '6 months after implant', 'description': 'Response is defined as a reduction \\>15% in LVESV, measured 6 months after implant.\n\nNon-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads.'}, {'measure': 'Number of Responder Patients With Conventional Left Ventricular Pacing Vector', 'timeFrame': '6 months after implant', 'description': 'Response is defined as a reduction \\>15% in LVESV, measured 6 months after implant.\n\nConventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CRT', 'Optimization', 'Responders'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Optimization and evolution of the patient will be evaluated over 6 months after the implant.', 'detailedDescription': 'Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart failure patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude Medical in the left ventricle.\n* Patient with an echocardiographic study performed during 1 month prior to the implant and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured\n* Patients who have granted their informed consent.\n* Patients above 18 years.\n\nExclusion Criteria:\n\n* Patients that have been previously resynchronized.\n* Patients with aortic stenosis or aortic valve prosthesis\n* Patients who are or may potentially be pregnant.\n* Patients with a life expectancy \\<12 months.\n* Patients who cannot attend the monitoring visits established by the protocol.'}, 'identificationModule': {'nctId': 'NCT01733368', 'acronym': 'QUARTO-II', 'briefTitle': 'QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead', 'orgStudyIdInfo': {'id': 'CR-1 2-015-SP-HF'}}, 'contactsLocationsModule': {'locations': [{'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Javier Alzueta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínico Universitario Virgen de la Victoria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}