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)

Ki vehet részt

• 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

Ki nem vehet részt

• Subject has ever had a previous or has an existing implantable pulse generator (IPG), implantable cardiac defibrillator (ICD) or biventricular (BiV) implant
• Subject is enrolled in a concurrent study that may confound the results of this study
• Subject has a mechanical heart valve
• Subject status post heart transplant
• Subject has LVEF < 45% if visually estimated at the time of enrollment
• Subject has more than mild para-valvular regurgitation following TAVR implantation
• Subject is indicated for a biventricular pacing device (CRT-P or CRT-D)
• Subject is pregnant, or of childbearing potential and not on a reliable form of birth control
• Subject life expectancy less than 2 years