Stopped: not enough participating site interest
The RAFT-TAVR PACE study is a clinical trial designed to compare two types of heart pacing methods in patients who develop conduction problems after undergoing a transcatheter aortic valve replacement (TAVR) procedure. This study will evaluate whether Left Bundle Branch Area Pacing (LBBAP), a newer and more natural pacing method, is better than the traditional Right Ventricular Pacing (RVP) at improving heart function and patient outcomes. The study aims to recruit 60 patients across six centers and will focus on the safety, feasibility, and success of LBBAP compared to RVP. Patients will be followed for one year to assess heart function, quality of life, and any complications related to the pacing method.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
CV Mortality and Heart Failure Events
Timeframe: from enrollment to the 12 month FU at minimum, with data collected every 6 months after until study completion at 5 year mark
Successful Enrollment and Randomization
Timeframe: from start of enrollment to end of vanguard/pilot phase of study, enrolling 60 patients
VANGUARD - Successful implantation of devices
Timeframe: Vanguard phase - from enrollment to the 60th patient being enrolled and followed up at 12 month FU point
VANGUARD - at least 90% ventricular pace at 3 months follow up
Timeframe: enrollment to 3 month FU timepoint