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)

Main Line Health

Status

Active, not recruiting

Conditions

High Degree Second Degree Atrioventricular Block

Aortic Valve Stenosis

Complete Heart Block

Pacemaker-Induced Cardiomyopathy

Treatments

Device: Left bundle branch area pacing followed by right ventricular septal pacing

Device: Right ventricular septal pacing followed by left bundle branch area pacing

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05541679

E-22-5212

Details and patient eligibility

About

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.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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