Biventricular or left bundle branch pacing to improve heart pumping after 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

This research will try whether implanting a cardiac resynchronization device (biventricular or left bundle branch pacing) shortly after TAVI helps people who develop a persistent left bundle branch block and have mildly reduced heart function (EF 35%–55%).

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Semmelweis University Heart and Vascular Center (other)
• Locations: 1 site (Budapest)
• Trial ID: NCT07434193 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with a successful, uncomplicated TAVI who have new-onset persistent LBBB wider than 130 ms at planned discharge and mildly reduced LV systolic function (EF 35%–55%), who provide informed consent and have no prior pacemaker/ICD or other exclusionary conditions, are ideal candidates.

Not a fit: Patients with pre-existing right bundle branch block, prior pacemaker/ICD with significant ventricular pacing, severe other valvular disease, active severe infection, or those without persistent LBBB or with preserved EF are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, early CRT could reduce heart failure admissions and deaths and improve left ventricular function and remodeling in patients who develop persistent LBBB after TAVI.

How similar studies have performed: Conventional CRT is proven in classic LBBB with markedly reduced EF, but applying early CRT specifically for new persistent LBBB after TAVI and using left bundle branch pacing is less established and relatively novel.

Eligibility criteria

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 this trial is running

Budapest

• 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

Conditions: Chronic Heart Failure, Cardiac Resynchronization Therapy