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

Recruiting now · Not applicable

Conditions studied: Chronic Heart Failure

In brief

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.

Key facts

Study ID

NCT07434193

Run by

Semmelweis University Heart and Vascular Center

People needed

360

Starts

2025-11-19

Expected to finish

2033-01-31

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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 is running

• Semmelweis University, Heart and Vascular Center — Budapest, Hungary (enrolling)

Full record on ClinicalTrials.gov

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