Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:55 AM
Study NCT ID:
NCT07434193
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2033-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': '12 months', 'description': 'Elapsed time to heart failure hospitalisation or all-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Resynchronization Therapy'], 'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': "In this prospective, randomized, multicenter, open-label interventional clinical trial, the investigators' aim to test the effect of Cardiac Resynchronization Therapy (CRT) in cases of new-onset and persistent Left Bundle Branch Block (LBBB) occurring in the context of Transcatheter Aortic Valve Implantation (TAVI), in patients with moderately reduced left ventricular systolic function (35% \\< EF \\< 55%). The investigators hypothesize that in patients with persistent LBBB developing after TAVI and mildly reduced left ventricular systolic function (35% \\< EF \\< 55%), early postoperative CRT implantation favorably influences the process of myocardial reverse remodeling by reducing electromechanical dyssynchrony, thereby decreasing the combined endpoint of heart failure-related hospitalizations and mortality at one year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* Successful and complication-free TAVI implantation for significant aortic stenosis\n* Signed informed consent after detailed patient information\n* New-onset LBBB wider than 130 ms after TAVI, persisting at the time of planned discharge (assessed postoperatively on or after day 5)(21)\n* Mildly reduced left ventricular systolic function on echocardiography at the planned time of discharge (at the earliest on postoperative day 5), with EF between 35% and 55%\n\nExclusion Criteria:\n\n* Pre-existing right bundle branch block, or prior pacemaker/ICD implantation associated with significant (\\>20%) ventricular pacing\n\n * Progression of LBBB during hospitalization to a degree indicating pacemaker implantation (e.g., Mobitz II or third-degree AV block, alternating bundle branch block) before the planned discharge date\n * Concomitant severe valvular disease of other valves (mitral, pulmonary, or tricuspid)\n * Severe infection and/or septic state\n * TAVI-associated stroke\n * More than moderate paravalvular leak of the TAVI valve on postoperative echocardiography\n * EF \\< 35% or \\> 55% on echocardiography performed at the planned time of discharge\n * GOLD stage IV COPD\n * Chronic renal failure requiring regular dialysis\n * Concurrent participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT07434193', 'acronym': 'BUDAPEST-TAVI', 'briefTitle': 'Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University Heart and Vascular Center'}, 'officialTitle': 'Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation- the BUDAPEST CRT TAVI Trial', 'orgStudyIdInfo': {'id': 'BUDAPEST CRT TAVI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CRT', 'description': 'CRT implantation', 'interventionNames': ['Device: CRT implantation']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care'}], 'interventions': [{'name': 'CRT implantation', 'type': 'DEVICE', 'description': 'CRT implantation in patients with LVEF between 35-55% and new-onset LBBB wider than 130 ms after TAVI implantation', 'armGroupLabels': ['CRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1122', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Mihály Ruppert, MD, PhD', 'role': 'CONTACT', 'email': 'merkely.study@gmail.com', 'phone': '+3614586810'}, {'name': 'Annamaria Kosztin, MD, PhD', 'role': 'CONTACT', 'email': 'kosztin.annamaria@semmelweis.hu'}, {'name': 'Béla Merkely, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Semmelweis University, Heart and Vascular Center', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'centralContacts': [{'name': 'Mihály Ruppert', 'role': 'CONTACT', 'email': 'merkely.study@gmail.com', 'phone': '+3614586810'}, {'name': 'Annamaria Kosztin', 'role': 'CONTACT', 'email': 'kosztin.annamaria@semmelweis.hu'}], 'overallOfficials': [{'name': 'Bela Merkely', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University, Heart and Vascular Center, Budapest, Hungary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University Heart and Vascular Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}