Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 10:35 PM
Study NCT ID:
NCT00658203
Status:
COMPLETED
Last Update Posted:
2008-04-14
First Post:
2008-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation on Advanced Resynchronization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-07', 'studyFirstSubmitDate': '2008-03-28', 'studyFirstSubmitQcDate': '2008-04-07', 'lastUpdatePostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The primary endpoint will be evaluated at 1 year (M12), in term of improved, unchanged or worsened patient's conditions, with a composite analysis of NYHA class evolution, heart-failure-related hospitalisations and Quality of Life evaluation.", 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': "PEA-CRT optimisation is at least effective as the standard optimisation in term of efficacy of the therapy and patients' quality of life.", 'timeFrame': '12 months'}, {'measure': "PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms.", 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of NYHA', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of BNP dosage', 'timeFrame': '12 months'}, {'measure': "Efficacy of the therapy comparing the two arms in terms of Number and duration of heart-failure-related patient's hospitalisations, during the study period.", 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Diastolic Diameter', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Systolic Diameter', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Left Ventricular Ejection Fraction', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Left Pre-Ejection Interval', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Right Pre-Ejection Interval', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Total Duration of Left Systole', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of E velocity', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of A velocity', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve closure interval', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve opening interval', 'timeFrame': '12 months'}, {'measure': 'Efficacy of the therapy comparing the two arms in terms of Mitral Valve regurgitation.', 'timeFrame': '12 months'}, {'measure': 'Time spent to achieve the CRT optimal configuration during each follow-up', 'timeFrame': '12 months'}, {'measure': "PEA monitoring and prognostic relevance correlating the PEA diagnostic trends with the parameters used to asses the efficacy of the therapy and patients' quality of life (NYHA class, mortality, HF-hospitalisation, EuroQoL-5D score, BNP dosage, Echo", 'timeFrame': '12 months'}, {'measure': '(LVEF) comparing the changes Left Ventricular Ejection Fraction in the two arms with an intermediate analysis at 6 months done by a Core Centre.', 'timeFrame': '6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CRT-P', 'PEA', 'Severe Heart Failure (NYHA Class III or IV)', 'Cardiomyopathy of any etiology', 'Sinus rhythm', 'Reduced Left-Ventricular Ejection Fraction', 'LVEDD>30 mm/m2', 'QRS Duration: > 150 ms or > 120 ms', 'Aortic Pre-Ejection Delay > 140 ms', 'Interventricular Mechanical Delay > 40 ms', 'Delayed activation of postero-lateral Left Ventricular wall', 'Optimal and stable pharmacological treatment'], 'conditions': ['Heart Failure', 'Cardiomyopathy']}, 'descriptionModule': {'briefSummary': "The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.\n\nPEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak Endocardial Acceleration sensor features onboard the device.", 'detailedDescription': "The study is a prospective, multicentre, controlled and randomised clinical investigation, with two single-blinded arms.\n\nThe objective of the study is to compare the clinical benefits of Cardiac Resynchronisation Therapy (CRT) optimised by automatic PEA sensor features (PEA-CRT), with those obtained by standard optimisation procedure (STD-CRT).\n\nThe patient candidate for inclusion in the study has a severe chronic Heart Failure, indicated for the implantation of a Biventricular pacing system according to updated ESC guidelines (2005).\n\nAll patients included in the study will be followed-up for 1 year; patient's follow-ups are scheduled during hospitalisation, at one month, 3 months, 6 months and one year after implantation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patient candidate for inclusion in the study must be indicated for implantation of a Biventricular pacing system, with the following clinical conditions:\n\n* Severe Heart Failure (NYHA Class III or IV)\n* Cardiomyopathy of any etiology\n* Sinus rhythm\n* Reduced Left-Ventricular Ejection Fraction\n* Left-Ventricular End Diastolic Diameter greater than or equal to 30 mm/m2 (LVEDD\\>30 mm/m2)\n* QRS Duration:\n\n * \\> 150 ms or\n * \\> 120 ms and documented Mechanical Dissynchrony (by ECHO) meeting two out of three of the following criteria:\n\n * Aortic Pre-Ejection Delay \\> 140 ms\n * Interventricular Mechanical Delay \\> 40 ms\n * Delayed activation of postero-lateral Left Ventricular wall (after mitral valve opening)\n* Optimal and stable (1 month before inclusion) pharmacological treatment, including, if tolerated, Beta Blockers, Angiotensin-Converting Enzyme (ACE) Inhibitors or ACE Inhibitor substitutes, Spironolactone, and diuretics\n\nExclusion Criteria:\n\nAny patient who has one of the following characteristics will be excluded from the study:\n\n* ICD indication (Life-threatening ventricular arrhythmias)\n* Persistent or permanent Atrial Arrhythmia without possibility to restore sinus rhythm (spontaneous termination, anti-tachycardia pacing, pharmacological or electrical cardioversion).\n* Patient already implanted with a conventional pacemaker device\n* Myocardial infarction within the last three months\n* Heart surgery, or revascularization within the last three months, or expected\n* Heart surgery refused because of co-morbidity factors\n* Included in transplantation list\n* Already enrolled in other study\n* Life expectancy less than 1 year\n* Pregnancy\n* Age less than 18\n* Forfeiture of freedom or under guardianship\n* Not able to understand the aim of the study and its procedures\n* Refusing to cooperate'}, 'identificationModule': {'nctId': 'NCT00658203', 'briefTitle': 'Clinical Evaluation on Advanced Resynchronization', 'organization': {'class': 'INDUSTRY', 'fullName': 'LivaNova'}, 'officialTitle': 'Clinical Evaluation on Advanced Resynchronization', 'orgStudyIdInfo': {'id': 'CLEAR - IPEA01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'PEA optimized CRT', 'interventionNames': ['Device: New Living CHF']}, {'type': 'OTHER', 'label': '2', 'description': 'Standard optimized CRT', 'interventionNames': ['Device: New Living CHF']}], 'interventions': [{'name': 'New Living CHF', 'type': 'DEVICE', 'description': 'PEA CRT optimization', 'armGroupLabels': ['1']}, {'name': 'New Living CHF', 'type': 'DEVICE', 'description': 'Standard optimized CRT.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Albi', 'country': 'France', 'facility': 'CH Albi', 'geoPoint': {'lat': 43.9298, 'lon': 2.148}}, {'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Lomme', 'country': 'France', 'facility': 'CH Lomme', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'country': 'France', 'facility': 'NC Nantaises', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Pau', 'country': 'France', 'facility': 'CH Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHR Cardiologie A', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'CH Yves le Foll', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'Saint-Cloud', 'country': 'France', 'facility': 'InParys Cardiology', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'UKB Unfallkrankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Homburg', 'country': 'Germany', 'facility': 'Univ Saarland', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'city': 'München', 'country': 'Germany', 'facility': 'Stiftsklinikum Augustinum', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Reinbek', 'country': 'Germany', 'facility': 'St.Adolfstift', 'geoPoint': {'lat': 53.51703, 'lon': 10.2488}}, {'city': 'Carpi', 'country': 'Italy', 'facility': 'Osp. B. Ramazzini', 'geoPoint': {'lat': 44.78237, 'lon': 10.8777}}, {'city': 'Desio', 'country': 'Italy', 'facility': 'Osp. Civile', 'geoPoint': {'lat': 45.61831, 'lon': 9.20249}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Osp. S. Maria Nuova', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Osp. Univ. Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Osp. Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Rieti', 'country': 'Italy', 'facility': 'Osp. Civile', 'geoPoint': {'lat': 42.40476, 'lon': 12.85735}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Osp. S. Filippo Neri', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Medisch Centrum Rijnmond-Zuid', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Diaconessenhuis', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Vlaardingen', 'country': 'Netherlands', 'facility': 'Vlietland Ziekenhuis', 'geoPoint': {'lat': 51.9125, 'lon': 4.34167}}, {'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'H. General Universit.', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'H. Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'H. General Universit.', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hosp. Clinico', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'city': 'Chertsey', 'country': 'United Kingdom', 'facility': "Saint Peter's Hospital", 'geoPoint': {'lat': 51.38812, 'lon': -0.50782}}, {'city': 'Eastbourne', 'country': 'United Kingdom', 'facility': 'General Hospital', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Nothern General', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'P Ritter, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'InParys Cardiologie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LivaNova', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'P. RITTER - Principal investigator', 'oldOrganization': 'InParys'}}}}