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NCT05541679 · ClinicalTrials.gov registry record · NA
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)
A NA study of Aortic Valve Stenosis and Complete Heart Block, sponsored by Main Line Health.
- Active
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 4
- Study locations
NCT05541679: Active NA study of Aortic Valve Stenosis and Complete Heart Block, sponsored by Main Line Health.
NCT05541679 is a NA study of Aortic Valve Stenosis and Complete Heart Block that is active but no longer recruiting, run by Main Line Health. The registered enrollment target is 46 participants, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05541679, a NA study of Aortic Valve Stenosis and Complete Heart Block, is active but no longer recruiting, sponsored by Main Line Health.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Primary efficacy outcome
Conditions Studied
Interventions
- DEVICE Right ventricular septal pacing followed by left bundle branch area pacing
- DEVICE Left bundle branch area pacing followed by right ventricular septal pacing
Study Locations (4)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- Lankenau Medical Center - Wynnewood
Kansas
- Kansas City Heart Rhythm Institute - Overland Park
New Jersey
- Valley Health System - Ridgewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2022-12-28 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the registry record for NCT05541679 still lists
NCT05541679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,042-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Right ventricular septal pacing followed by left bundle branch area pacing is the first listed.
NCT05541679 reports a single indexed study location in Pennsylvania, Kansas, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05541679 about?
NCT05541679 is a clinical study titled "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)". 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, multic...
What is the current status of trial NCT05541679?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 46 participants. The study started on 2022-12-28. Estimated completion is 2025-12-31.
What conditions does trial NCT05541679 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis, Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy.
What interventions are being tested in trial NCT05541679?
The interventions under investigation include: Right ventricular septal pacing followed by left bundle branch area pacing (DEVICE), Left bundle branch area pacing followed by right ventricular septal pacing (DEVICE).
Who is sponsoring clinical trial NCT05541679?
This trial is sponsored by Main Line Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05541679 being conducted?
This trial has 4 study locations across Kansas, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05541679's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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