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

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.

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