Chronic Heart Failure
Conditions
Keywords
Cardiac Resynchronization Therapy
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.
Interventions
DEVICECRT implantation
CRT implantation in patients with LVEF between 35-55% and new-onset LBBB wider than 130 ms after TAVI implantation
Sponsors
Semmelweis University Heart and Vascular Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 12 months | Elapsed time to heart failure hospitalisation or all-cause mortality |
Countries
Hungary
Contacts
CONTACTMihály Ruppert
CONTACTAnnamaria Kosztin
PRINCIPAL_INVESTIGATORBela Merkely
Semmelweis University, Heart and Vascular Center, Budapest, Hungary
Outcome results
None listed