Actively Recruiting
Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation
Led by Semmelweis University Heart and Vascular Center · Updated on 2026-02-25
360
Participants Needed
1
Research Sites
375 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (on or after postoperative day 5)
- Mildly reduced left ventricular systolic function on echocardiography at planned discharge, with EF between 35% and 55%
You will not qualify if you...
- Pre-existing right bundle branch block or prior pacemaker/ICD implantation with >20% ventricular pacing
- Progression of LBBB during hospitalization requiring pacemaker implantation before planned discharge
- Severe valvular disease of mitral, pulmonary, or tricuspid valves
- Severe infection or septic state
- Stroke related to TAVI
- More than moderate paravalvular leak of the TAVI valve on postoperative echocardiography
- EF less than 35% or greater than 55% at planned discharge echocardiography
- GOLD stage IV COPD
- Chronic renal failure requiring regular dialysis
- Participation in another clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Semmelweis University, Heart and Vascular Center
Budapest, Hungary, 1122
Actively Recruiting
Research Team
M
Mihály Ruppert
CONTACT
A
Annamaria Kosztin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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