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NCT Number: NCT07434193

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University, Heart and Vascular Center

Budapest, 1122, Hungary

Location status: Recruiting

Location contact

Annamaria Kosztin, MD, PhD

CONTACT

[email protected]

Béla Merkely, Professor

PRINCIPAL_INVESTIGATOR

Mihály Ruppert, MD, PhD

CONTACT

[email protected]

+3614586810

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRT implantation

Device

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

Primary outcomes

  1. Primary outcome

    Time frame: 12 months

    Elapsed time to heart failure hospitalisation or all-cause mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Annamaria Kosztin

CONTACT

[email protected]

Mihály Ruppert

CONTACT

[email protected]

+3614586810

Sponsors and collaborators

Lead sponsor

Semmelweis University Heart and Vascular Center

Other

Registry information

Official study title

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

Acronym: BUDAPEST-TAVI

Important dates

Study start
2025
Primary completion
2033
Study completion
2033
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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