Trials / Active Not Recruiting
Active Not RecruitingNCT05541679
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)
Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- Sponsor
- Main Line Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Complete Heart Block
- High Degree Second Degree Atrioventricular Block
- Pacemaker-Induced Cardiomyopathy
- Aortic Valve Stenosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Right ventricular septal pacing followed by left bundle branch area pacing | All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study. |
| DEVICE | Left bundle branch area pacing followed by right ventricular septal pacing | All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study. |
Timeline
- Start date
- 2022-12-28
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2022-09-15
- Last updated
- 2024-12-10
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05541679. Inclusion in this directory is not an endorsement.