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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: CRT implantation

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mihály Ruppert; Phone Number: +3614586810; Email: merkely.study@gmail.com
• Study Contact Backup: Name: Annamaria Kosztin; Email: kosztin.annamaria@semmelweis.hu

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Recruiting
    • Semmelweis University, Heart and Vascular Center
    • Contact: Mihály Ruppert, MD, PhD; Phone Number: +3614586810; Email: merkely.study@gmail.com
    • Contact: Annamaria Kosztin, MD, PhD; Email: kosztin.annamaria@semmelweis.hu
    • Principal Investigator: Béla Merkely, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care
Active Comparator: CRT; CRT implantation	Device: CRT implantation; CRT implantation in patients with LVEF between 35-55% and new-onset LBBB wider than 130 ms after TAVI implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	Elapsed time to heart failure hospitalisation or all-cause mortality	12 months

Collaborators and Investigators

• Sponsor: Semmelweis University Heart and Vascular Center
• Investigators: Principal Investigator: Bela Merkely, Semmelweis University, Heart and Vascular Center, Budapest, Hungary

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2025
• Primary Completion (Estimated): January 31, 2033
• Study Completion (Estimated): January 31, 2033

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac Resynchronization Therapy
• Other Study ID Numbers: BUDAPEST CRT TAVI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No