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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) | Clinical Trials | Clareo Health

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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)

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

NCT05541679•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has at least one of these conduction disturbances:
•1. Symptomatic (or hemodynamically significant) bradycardia or symptomatic persistent atrioventricular block including first-degree and Mobitz I (Wenckebach) or Mobitz type II atrioventricular bock
•2. High-grade atrioventricular block
•3. Third-degree atrioventricular block
•Subject has undergone TAVR (any valve system) in the last four weeks
•Subject is receiving a first-time pacemaker implant
•Subject's most recent documented ejection fraction (by any method) within the past 90 days prior to study enrollment is \> 50% (≥45% if visually estimated at the time of enrollment)
•Subject is a male or female at least 18 years old at the time of consent
•Subject is able to receive a left sided pectoral implant

Exclusion Criteria

•Subject has ever had a previous or has an existing implantable pulse generator (IPG), implantable cardiac defibrillator (ICD) or biventricular (BiV) implant
•Subject has more than mild para-valvular regurgitation following TAVR implantation.
•Subject has LVEF \< 45% if visually estimated at the time of enrollment
•Subject is indicated for a biventricular pacing device (CRT-P or CRT-D).
•Subject is enrolled in a concurrent study that may confound the results of this study
•Subject has a mechanical heart valve
•Subject is pregnant, or of childbearing potential and not on a reliable form of birth control
•Subject status post heart transplant
•Subject life expectancy less than 2 years

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

Key Dates

Start Date

December 28, 2022

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

December 10, 2024

Enrollment

ESTIMATED participants

Conditions

Complete Heart BlockHigh Degree Second Degree Atrioventricular BlockPacemaker-Induced CardiomyopathyAortic Valve Stenosis

Interventions

Right ventricular septal pacing followed by left bundle branch area pacing

DEVICE

Left bundle branch area pacing followed by right ventricular septal pacing

DEVICE

Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy

NCT06474819

Complete Heart BlockSecond Degree Atrioventricular Block Möbitz Type II

View study

COMPLETEDNA

Conduction System Stimulation to Avoid Left Ventricle Dysfunction

NCT06026683

Atrioventricular Block, Second and Third DegreePacemaker-Induced Cardiomyopathy+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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