Actively Recruiting
Biventricular or Left Bundle Branch Pacing to Assess the Effect of Cardiac Resynchronization Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation - the BUDAPEST CRT TAVI Trial
Led by Semmelweis University Heart and Vascular Center · Updated on 2026-02-25
360
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of Cardiac Resynchronization Therapy (CRT) in patients who develop new and persistent Left Bundle Branch Block (LBBB) after Transcatheter Aortic Valve Implantation (TAVI) and have a moderately reduced left ventricular function with an ejection fraction between 35% and 55%. The study aims to see if early CRT implantation after TAVI can improve heart muscle function and reduce hospitalizations and mortality related to heart failure within one year. This is a prospective, randomized, multicenter, open-label interventional trial sponsored by Semmelweis University Heart and Vascular Center. Participants will be randomly assigned to receive either CRT implantation or standard care without intervention. CRT implantation involves placing a device in patients with new LBBB wider than 130 milliseconds after TAVI and mildly reduced heart function. The study compares outcomes between those receiving CRT and those receiving usual care to assess the therapy's impact on heart remodeling and clinical events. During the study, participants will be closely monitored with echocardiography and clinical evaluations starting from postoperative day 5 to confirm eligibility and assess heart function. The primary outcome is measured at 12 months, focusing on heart failure-related hospitalizations and mortality. Participants will be followed to observe changes in heart function and any adverse events. The total participation duration includes the initial implantation and a one-year follow-up period.
CONDITIONS
Brief 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 Transcatheter Aortic Valve Implantation (TAVI) for significant aortic stenosis
- Signed informed consent after detailed patient information
- New-onset Left Bundle Branch Block (LBBB) wider than 130 ms after TAVI, persisting at discharge (postoperative day 5 or later)
- Mildly reduced left ventricular systolic function with ejection fraction between 35% and 55% at discharge (earliest postoperative day 5)
You will not qualify if you...
- Pre-existing right bundle branch block or prior pacemaker/ICD implantation with significant (>20%) ventricular pacing
- Progression of LBBB during hospitalization requiring pacemaker implantation before discharge
- Severe valvular disease of mitral, pulmonary, or tricuspid valves
- Severe infection or septic condition
- Stroke associated with TAVI
- More than moderate paravalvular leak of the TAVI valve on postoperative echocardiography
- Ejection fraction below 35% or above 55% at discharge
- GOLD stage IV chronic obstructive pulmonary disease (COPD)
- Chronic renal failure requiring regular dialysis
- Concurrent participation in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Postoperative day 5 or later
Participants undergo CRT implantation if randomized to the intervention group after successful Transcatheter Aortic Valve Implantation (TAVI).
1 visit (in-person) for implantation
Duration - 12 months
Participants are monitored for 12 months to assess the effect of cardiac resynchronization therapy.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Semmelweis University, Heart and Vascular Center
Budapest, Hungary, 1122
Actively Recruiting
Research Team
M
Mihály Ruppert
A
Annamaria Kosztin
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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