Clareo Health | 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 (Left Bundle BRAVE)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Main Line Health
With
Sharpe-Strumia Research Foundation
Medtronic
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be 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
