RAFT-TAVR PACE: LBBAP vs. RVP Post-TAVR in Patients Requiring PPI
Megadott ok: not enough participating site interest
A vizsgálat adatai
- Ki végzi
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Azonosító
- NCT06857201
- A regiszteradat frissítve
- 2026. április 21.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Randomized Assessment of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Post-TAVR Patients With Persistent High-Degree Atrioventricular Block or Complete Heart Block Requiring Permanent Pacemaker Implantation
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.
Bevonási feltételek: Successful insertion of TAVR for aortic stenosis; Persistent HDAVB or CHB identified within 30 days of TAVR; ● HDAVB is defined as any of the following(9): Second-degree AV block type 2 (Mobitz II) in the presence of a QRS ≥120 msec, or 2:1 AV block in the presence of a QRS ≥120 msec, or ≥2 consecutive P waves at a constant physiologic rate that do not conduct to the ventricles, or transient third-degree AV block, or in the setting of AF a prolonged pause (>3 s) or a fixed slow (<50 beats/min) ventricular response rate; Age ≥ 18 years.
Kizáró feltételek: Patients with a pacemaker/ICD/CRT prior to TAVR; Cardiogenic shock requiring inotropic therapy within 1 week; Un-revascularized coronary artery disease with proximal multi-vascular coronary disease; Acute coronary syndrome with 3 months; Anticipating heart transplant within 1 year; Renal failure - eGFR<15 or on dialysis; Life-expectancy < 2 years; More than mild para-valvular regurgitation following TAVR; Patients with clinical indication for CRT-D or CRT-P; Patients with mechanical tricuspid valve; Pregnant or intending to become pregnant within the study period; Participating in another randomized controlled trial; Unable or unwilling to provide consent.