Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03779802
Status:
TERMINATED
Last Update Posted:
2020-05-22
First Post:
2018-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Multicentric Study Comparing the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization Therapy Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047548', 'term': 'Defibrillators'}], 'ancestors': [{'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'With the current health situation, we do not anticipate a significant resumption of recruitment for several months.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-20', 'studyFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic response', 'timeFrame': 'day 0', 'description': 'Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation'}], 'secondaryOutcomes': [{'measure': 'Other hemodynamical response', 'timeFrame': 'day 0', 'description': 'Cardiac output'}, {'measure': 'Other hemodynamical response', 'timeFrame': 'day 0', 'description': 'Systolic ejection volume'}, {'measure': 'Other hemodynamical response', 'timeFrame': 'day 0', 'description': 'dP/dT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Resynchronization Therapy', 'Atrioventricular delay optimization', 'Multipoint pacing', 'Negative atrioventricular hysteresis', 'Non invasive hemodynamic optimization', 'Heart Failure'], 'conditions': ['Heart Failure', 'Cardiac Resynchronization Therapy']}, 'referencesModule': {'references': [{'pmid': '33128179', 'type': 'DERIVED', 'citation': 'Ferchaud V, Garcia R, Bidegain N, Degand B, Milliez P, Pezel T, Moubarak G. Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2021 Nov;62(2):347-356. doi: 10.1007/s10840-020-00908-6. Epub 2020 Oct 30.'}]}, 'descriptionModule': {'briefSummary': 'Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality.\n\nAdjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of stimulation can influence the acute hemodynamical consequences of CRT but also its medium-term and long-term clinical and echocardiographic effects.\n\nThe aim of the present prospective study is to investigate whether the different stimulation modes lead to different acute hemodynamic response, by evaluating the highest systolic pressure using the Finapress ® method.', 'detailedDescription': 'This study is a non-randomized, prospective, interventional, multicentric study.\n\nPatients implanted with an Abbott ® CRT pacemaker or defibrillator since less than 3 months are eligible for the study.\n\nRecruited patients will be submitted to a non-invasive evaluation of different pacing modes. This will be performed using the Finapress NOVA device, which records blood pressure with a digital cuff. The peak of blood pressure will correspond to the optimal device settings\n\nThree modes of stimulation of ABBOTT CRT devices will be compared:\n\n* Classical bi-ventricular pacing mode at nominal value and with AV delay optimization\n* SyncAV mode at nominal value or with left ventricular preexcitation optimization\n* Multipoint Pacing (MPP) mode, alone or in combination with SyncAV mode This is an acute evaluation study without scheduled follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient older than 18\n* Implantation of a CRT (CRT-P or CRT-D) less than 3 months before inclusion\n* MPP and SyncAV-enabled ABBOTT Quadripolar CRT pacing system\n* Patient who had signed an informed consent and is willing to comply with study requirements\n* De novo implantation\n* Patient covered by national healthcare insurance\n\nExclusion Criteria:\n\n* Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia\n* Pacing indication for 2nd or 3rd degree AV block\n* Upgrading from non-CRT system\n* Pregnant or breastfeeding women\n* Adult under legal protection'}, 'identificationModule': {'nctId': 'NCT03779802', 'acronym': '3 STIM', 'briefTitle': 'Prospective Multicentric Study Comparing the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization Therapy Recipients', 'organization': {'class': 'OTHER', 'fullName': 'CMC Ambroise Paré'}, 'officialTitle': 'Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.', 'orgStudyIdInfo': {'id': '2018/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CRT device', 'description': 'Patients implanted with a CRT device who will undergo a non-invasive hemodynamic evaluation of different pacing modes', 'interventionNames': ['Other: Device programming of ABBOTT CRT pacemaker or defibrillator']}], 'interventions': [{'name': 'Device programming of ABBOTT CRT pacemaker or defibrillator', 'type': 'OTHER', 'description': 'Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session.', 'armGroupLabels': ['CRT device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95600', 'city': 'Eaubonne', 'state': "Val-d'Oise", 'country': 'France', 'facility': "Gehm Site D'Eaubonne", 'geoPoint': {'lat': 48.99712, 'lon': 2.28249}}, {'zip': '92200', 'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': 'Cmc Ambroise Pare', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}, {'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'Ghassan MD MOUBARAK', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CMC Ambroise Paré'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMC Ambroise Paré', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}