Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Ther… (NCT07434193) | Clinical Trial Compass
RecruitingNot Applicable
Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation
Hungary360 participantsStarted 2025-11-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Primary outcome
Timeframe: 12 months
Trial details
NCT IDNCT07434193
SponsorSemmelweis University Heart and Vascular Center