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)

Overview

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

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