NCT07434193 Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation
| NCT ID | NCT07434193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Semmelweis University Heart and Vascular Center |
| Condition | Chronic Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2033-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2025-11-19 with a primary completion date of 2033-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Bela Merkely
PRINCIPAL INVESTIGATOR
Semmelweis University, Heart and Vascular Center, Budapest, Hungary
Frequently Asked Questions
Who can join the NCT07434193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07434193 currently recruiting?
Yes, NCT07434193 is actively recruiting participants. Contact the research team at merkely.study@gmail.com for enrollment information.
Where is the NCT07434193 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT07434193 clinical trial?
NCT07434193 is sponsored by Semmelweis University Heart and Vascular Center. The principal investigator is Bela Merkely at Semmelweis University, Heart and Vascular Center, Budapest, Hungary. The trial plans to enroll 360 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.