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)
Running, not enrolling · Not applicable
Conditions studied: Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy, Aortic Valve Stenosis
In brief
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.
Key facts
- Study ID
- NCT05541679
- Run by
- Main Line Health
- People needed
- 46
- Starts
- 2022-12-28
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2024-12-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 (Wenckebach) or Mobitz type II atrioventricular bock
- High-grade atrioventricular block
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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