Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement (Left Bundle BRAVE)
AI Description
The purpose of the study is to investigate the superiority of chronic left bundle branch area pacing compared to traditional right ventricular (RV) septal pacing in patients with high-grade conduction disease after transcatheter aortic valve replacement (TAVR). In this investigator initiated, multicenter, prospective, double-blinded, crossover study, chronic left bundle branch area pacing will be compared to chronic right ventricular septal pacing using echocardiographic measures of left ventricular systolic function in patients with a high cumulative ventricular pacing burden after TAVR.
- Who can join
- adult, older adult
- Participants
- 46
- Expected completion
- 2025-12-31
- Funded by
- other
Conditions studied
Aortic Valve Stenosis, Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy
What is being tested
- DEVICE: Left bundle branch area pacing followed by right ventricular septal pacing
- DEVICE: Right ventricular septal pacing followed by left bundle branch area pacing
What it measures
- Change in global longitudinal strain (GLS%), Primary efficacy outcome, 9 months
- Change in left ventricular ejection fraction (LVEF%), Primary efficacy outcome, 9 months
- Composite of left bundle branch area pacing lead septal myocardial or coronary artery perforation, lead dislodgment, and repeat procedures related to left bundle branch area lead implantation, Primary safety endpoint, 18 months
Working with
Medtronic, Sharpe-Strumia Research Foundation
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2024-12-10
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.