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ACTIVE NOT RECRUITING
NCT05541679
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)

Sponsor: Main Line Health

View on ClinicalTrials.gov

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.

Official title: Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2022-12-28

Completion Date

2025-12-31

Last Updated

2024-12-10

Healthy Volunteers

No

Interventions

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.

Locations (4)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Valley Health System

Ridgewood, New Jersey, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States