RecruitingNot ApplicableNCT07434193

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

Sponsor

Semmelweis University Heart and Vascular Center

Enrollment

360 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Heart Failure

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two types of pacing strategies — biventricular pacing (stimulating both sides of the heart) and left bundle branch pacing (stimulating the heart's natural electrical pathway) — for people who develop a new heart conduction problem (left bundle branch block) after receiving a TAVI heart valve replacement. **You may be eligible if...** - You are 18 or older - You recently had a successful TAVI procedure (a minimally invasive heart valve replacement for aortic stenosis — a narrowing of the heart valve) - You developed a new left bundle branch block after the procedure that is still present at the time of planned discharge - Your heart pumping function is mildly reduced on echocardiogram (heart ultrasound) - You have provided informed consent **You may NOT be eligible if...** - You had complications during your TAVI procedure - You had a pre-existing left bundle branch block before the TAVI - You are in very poor general health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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