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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)
NCT05541679 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05541679
The ClinicalTrials.gov registry entry for NCT05541679 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Main Line Health, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05541679 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Pennsylvania, Kansas, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05541679?
This trial is sponsored by Main Line Health, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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