Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-21 @ 1:35 AM
Study NCT ID:
NCT05985408
Status:
UNKNOWN
Last Update Posted:
2023-08-14
First Post:
2023-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LVSP Based CRT vs. RVAP Based CRT
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2023-08-03', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'left ventricular ejection fraction (LVEF)', 'timeFrame': '6 months', 'description': "LVEF evaluated by echocardiography，Bi-plane Simpson's method"}, {'measure': 'left ventricular ejection fraction (LVEF)', 'timeFrame': '12 months', 'description': "LVEF evaluated by echocardiography，Bi-plane Simpson's method"}, {'measure': 'left ventricular end-systolic volume (LVESV)', 'timeFrame': '6 months', 'description': 'LVESV evaluated by echocardiography'}, {'measure': 'left ventricular end-systolic volume (LVESV)', 'timeFrame': '12 months', 'description': 'LVESV evaluated by echocardiography'}], 'secondaryOutcomes': [{'measure': 'paced QRSd duration.', 'timeFrame': '6 months', 'description': 'QRS duration measurement after the procedure'}, {'measure': 'paced QRSd duration.', 'timeFrame': '12 months', 'description': 'QRS duration measurement after the procedure'}, {'measure': 'NT-proBNP', 'timeFrame': '6 months', 'description': 'Serum NT-proBNP level'}, {'measure': 'NT-proBNP', 'timeFrame': '12 months', 'description': 'Serum NT-proBNP level'}, {'measure': '6-minute hall walk distance', 'timeFrame': '6 months', 'description': '6-minute hall walk distance'}, {'measure': '6-minute hall walk distance', 'timeFrame': '12 months', 'description': '6-minute hall walk distance'}, {'measure': 'Heart failure rehospitalization', 'timeFrame': '6 months', 'description': 'Rehospitalization due to the exacerbation of heart failure'}, {'measure': 'Heart failure rehospitalization', 'timeFrame': '12 months', 'description': 'Rehospitalization due to the exacerbation of heart failure'}, {'measure': 'Rehospitalization for cardiovascular adverse events', 'timeFrame': '12 months', 'description': 'Rehospitalization for cardiovascular adverse events'}, {'measure': 'Malignant ventricular arrhythmias', 'timeFrame': '6 months', 'description': 'ICD therapy for ventricular tachycardia or ventricular fibrillation'}, {'measure': 'Malignant ventricular arrhythmias', 'timeFrame': '12 months', 'description': 'ICD therapy for ventricular tachycardia or ventricular fibrillation'}, {'measure': 'All cause death', 'timeFrame': '6 months', 'description': 'All cause death events'}, {'measure': 'All cause death', 'timeFrame': '12 months', 'description': 'All cause death events'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure', 'Cardiac Resynchronization Therapy', 'Left Ventricular Septal Pacing', 'Right Ventricular Septal Pacing']}, 'referencesModule': {'references': [{'pmid': '37211145', 'type': 'RESULT', 'citation': 'Ferrick AM, Raj SR, Deneke T, Kojodjojo P, Lopez-Cabanillas N, Abe H, Boveda S, Chew DS, Choi JI, Dagres N, Dalal AS, Dechert BE, Frazier-Mills CG, Gilbert O, Han JK, Hewit S, Kneeland C, DeEllen Mirza S, Mittal S, Ricci RP, Runte M, Sinclair S, Alkmim-Teixeira R, Vandenberk B, Varma N. 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Heart Rhythm. 2023 Sep;20(9):e92-e144. doi: 10.1016/j.hrthm.2023.03.1525. Epub 2023 May 19.'}, {'pmid': '36704478', 'type': 'RESULT', 'citation': 'Zhang J, Zhang Y, Sun Y, Chen M, Wang Z, Ma C. Success rates, challenges and troubleshooting of left bundle branch area pacing as a cardiac resynchronization therapy for treating patients with heart failure. Front Cardiovasc Med. 2023 Jan 10;9:1062372. doi: 10.3389/fcvm.2022.1062372. eCollection 2022.'}, {'pmid': '33930549', 'type': 'RESULT', 'citation': 'Curila K, Jurak P, Jastrzebski M, Prinzen F, Waldauf P, Halamek J, Vernooy K, Smisek R, Karch J, Plesinger F, Moskal P, Susankova M, Znojilova L, Heckman L, Viscor I, Vondra V, Leinveber P, Osmancik P. Left bundle branch pacing compared to left ventricular septal myocardial pacing increases interventricular dyssynchrony but accelerates left ventricular lateral wall depolarization. Heart Rhythm. 2021 Aug;18(8):1281-1289. doi: 10.1016/j.hrthm.2021.04.025. Epub 2021 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients with failed left bundle branch pacing at the beginning of chronic heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Chronic heart failure, LVEF ≤35% after at least 3 months of guideline-optimized drug therapy, NYHA class II-IV with complete left bundle branch block (QRSd≥130 ms), OR Atrioventricular block with LVEF ≤ 50% with the indication of cardiac pacing; 3. Age between 18 and 90 years old; 4. The expected survival period is greater than 12 months; 5. Signed the informed consent form for the study.\n\nExclusion Criteria:\n\n1. Previous mechanical tricuspid valve replacement.\n2. Previous pacemaker or other devices implanted and for device replacement or upgrading for this time.\n3. Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months.\n4. Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%.\n5. Patients participated in any of the other studies at the same time, which may confound the results of this study.\n6. Pregnancy, planning to become pregnant.\n\n8\\. Patients with a history of heart transplantation.'}, 'identificationModule': {'nctId': 'NCT05985408', 'briefTitle': 'LVSP Based CRT vs. RVAP Based CRT', 'organization': {'class': 'OTHER', 'fullName': 'Fu Wai Hospital, Beijing, China'}, 'officialTitle': 'Left Ventricular Septal Pacing Based Rescue CRT Versus Right Ventricular Apical Pacing Based CRT for Chronic Heart Failure: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023-0801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LVSP-CRT', 'description': 'Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy.', 'interventionNames': ['Device: left ventricular septal pacing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RVAP-CRT', 'description': 'Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy.', 'interventionNames': ['Device: right ventricular apical pacing']}], 'interventions': [{'name': 'left ventricular septal pacing', 'type': 'DEVICE', 'description': 'For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT.', 'armGroupLabels': ['LVSP-CRT']}, {'name': 'right ventricular apical pacing', 'type': 'DEVICE', 'description': 'For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT.', 'armGroupLabels': ['RVAP-CRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Xiaofei Li, Doctor', 'role': 'CONTACT', 'email': 'lixiaofei0103@163.com', 'phone': '17801013995'}], 'facility': 'Fuwai hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Wai Hospital, Beijing, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Li Xiaofei', 'investigatorAffiliation': 'Fu Wai Hospital, Beijing, China'}}}}