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

RecruitingNAAges 18 Years - anyAllSemmelweis University Heart and Vascular Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • CRT implantation
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Where

1 site
Semmelweis University, Heart and Vascular Center
Budapest, Hungary
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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