Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation

NCT07434193 | Recruiting DMC

• 1 other identifier: BUDAPEST CRT TAVI-001
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Heart Failure

Keywords

Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Elapsed time to heart failure hospitalisation or all-cause mortality

  12 months

Study Arms (2)

CRT

ACTIVE COMPARATOR

CRT implantation

Device: CRT implantation

Standard of Care

NO INTERVENTION

Interventions

CRT implantation DEVICE

CRT implantation in patients with LVEF between 35-55% and new-onset LBBB wider than 130 ms after TAVI implantation

CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Successful and complication-free TAVI implantation for significant aortic stenosis
• Signed informed consent after detailed patient information
• New-onset LBBB wider than 130 ms after TAVI, persisting at the time of planned discharge (assessed postoperatively on or after day 5)(21)
• 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%

You may not qualify if:

• Pre-existing right bundle branch block, or prior pacemaker/ICD implantation associated with significant (\>20%) ventricular pacing
• 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
• Concomitant severe valvular disease of other valves (mitral, pulmonary, or tricuspid)
• Severe infection and/or septic state
• TAVI-associated stroke
• More than moderate paravalvular leak of the TAVI valve on postoperative echocardiography
• EF \< 35% or \> 55% on echocardiography performed at the planned time of discharge
• GOLD stage IV COPD
• Chronic renal failure requiring regular dialysis
• Concurrent participation in another clinical trial

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead

Study Sites (1)

Semmelweis University, Heart and Vascular Center

Budapest, 1122, Hungary

RECRUITING

Study Officials

• Bela Merkely

  Semmelweis University, Heart and Vascular Center, Budapest, Hungary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihály Ruppert

CONTACT

+3614586810; merkely.study@gmail.com

Annamaria Kosztin

CONTACT

kosztin.annamaria@semmelweis.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 25, 2026
• Study Start: November 19, 2025
• Primary Completion (Estimated): January 31, 2033
• Study Completion (Estimated): January 31, 2033
• Last Updated: February 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)