Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation
Recruiting · NCT07434193 · Interventional (participants receive a specific treatment) · Lead sponsor: Semmelweis University Heart and Vascular Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Semmelweis University, Heart and Vascular Center - Budapest, Hungary