Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT04334018
Status:
WITHDRAWN
Last Update Posted:
2020-04-03
First Post:
2018-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi Point Pacing vs. Conventional STUDY PROTOCOL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Other studies on the same theme', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome 1', 'timeFrame': '12 months', 'description': 'To evaluate the clinical improvement of CRT MPP as compared to conventional CRT in Heart Failure patients with indication for CRT using automated intra-cardiac EGMs analysis (QuickOpt™) for device optimization, in a large multicentre international study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy']}, 'descriptionModule': {'briefSummary': 'The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months\n\nExclusion Criteria:\n\n* \\< 18 years and younger\n* Pregnant or breastfeeding patients\n* Non-LBBB patients (RBBB, intra-ventricular delay)\n* Non-ambulatory NYHA class IV effort tolerance\n* Myocardial infarction within 40 days before enrolment\n* Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months\n* Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery)\n* Patients with life expectancy of less than 12 months due to other medical conditions\n* Patients who are involved in another investigational study (device or medical)'}, 'identificationModule': {'nctId': 'NCT04334018', 'acronym': 'CRT-MPP', 'briefTitle': 'Multi Point Pacing vs. Conventional STUDY PROTOCOL', 'organization': {'class': 'OTHER', 'fullName': 'CMC Ambroise Paré'}, 'officialTitle': 'Observational, Multicentre, Investigator and Patient Blinded, Prospective, Randomized Comparator Study of Cardiac Resynchronization Therapy (CRT) Multi Point Pacing (MPP) Compared to Conventional CRT Pacing Response in Heart Failure Patients.', 'orgStudyIdInfo': {'id': '2017/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'conventional CRT', 'interventionNames': ['Device: conventional CRT']}, {'type': 'EXPERIMENTAL', 'label': 'MPP CRT', 'interventionNames': ['Device: MPP CRT']}], 'interventions': [{'name': 'conventional CRT', 'type': 'DEVICE', 'description': 'Conventional CRT or biventricular pacing "resynchronizes" left ventricular contraction by pacing the right and left ventricles (LV) simultaneously', 'armGroupLabels': ['conventional CRT']}, {'name': 'MPP CRT', 'type': 'DEVICE', 'description': 'CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously', 'armGroupLabels': ['MPP CRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06606', 'city': 'Antibes', 'country': 'France', 'facility': "PHc hôpital d'Antibes la Fontonne", 'geoPoint': {'lat': 43.58127, 'lon': 7.12487}}, {'zip': '06150', 'city': 'Cannes', 'country': 'France', 'facility': 'Centre hospitalier de Cannes', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'zip': '92200', 'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': 'CMC Ambroise Paré', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}, {'zip': '06100', 'city': 'Nice', 'country': 'France', 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '66000', 'city': 'Perpignan', 'country': 'France', 'facility': 'Centre Hospitalier de Perpignan', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '98000', 'city': 'Monaco', 'country': 'Monaco', 'facility': 'Centre Hospitalier Princesse Grace', 'geoPoint': {'lat': 43.73718, 'lon': 7.42145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMC Ambroise Paré', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}