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: Left Bundle BRAVE study

Objective

The purpose of this prospective, randomized, double-blind, crossover study is to determine if patients with high grade AV block after TAVR will benefit from left bundle branch area pacing (LBBAP) compared to right ventricular septal pacing as evidenced by improved LVEF and LV global longitudinal strain while they are assigned to LBBAP compared to traditional right ventricular septal pacing.

Eligibility

• Subject has at least one of these conduction disturbances:
  • Symptomatic (or hemodynamically significant) bradycardia or symptomatic persistent atrioventricular block including first-degree and Mobitz I (Wenchebach) or Mobitz type II atrioventricular bock
  • High-grade atrioventricular block
  • Third-degree atrioventricular block
• Subject has undergone TAVR (any valve system) in the last two 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%
• 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
• Subject is expected to remain available for follow-up visits at the study center
• Subject is willing and able to comply with the protocol
• Subject is able to able to understand the consent form.

NCT ID

NCT05541679