Biventricular or left bundle branch pacing to improve heart pumping after TAVI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, multicenter, open-label interventional trial comparing early postoperative cardiac resynchronization therapy (biventricular or left bundle branch pacing) versus standard care in patients who develop new persistent LBBB after TAVI and have an ejection fraction between 35% and 55%. Eligible patients are randomized after at least five days post-TAVI if LBBB wider than 130 ms persists at planned discharge, and receive CRT implantation early postoperatively or routine follow-up according to local practice. The primary outcome is a composite of heart failure hospitalizations and mortality at one year, with secondary assessments of left ventricular reverse remodeling and electromechanical dyssynchrony. The trial tests whether early CRT reduces electromechanical dyssynchrony and improves clinical outcomes and cardiac remodeling in this specific post-TAVI population.

Why it matters

Who can join: the full rules

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

Where it's running

• Semmelweis University, Heart and Vascular Center
  Budapest, Hungary Recruiting

Study contacts

• Principal investigator: Bela Merkely — Semmelweis University, Heart and Vascular Center, Budapest, Hungary
• Study coordinator: Mihály Ruppert
• Email: merkely.study@gmail.com
• Phone: +3614586810

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.