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)
NCT ID: NCT05541679
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
46 participants
INTERVENTIONAL
2022-12-28
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Group A
Right ventricular septal pacing followed by left bundle branch area pacing
All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study.
Group B
Left bundle branch area pacing followed by right ventricular septal pacing
All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study.
Interventions
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Right ventricular septal pacing followed by left bundle branch area pacing
All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study.
Left bundle branch area pacing followed by right ventricular septal pacing
All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study.
Eligibility Criteria
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Inclusion Criteria
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 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
18 Years
ALL
No
Sponsors
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Sharpe-Strumia Research Foundation
OTHER
Medtronic
INDUSTRY
Main Line Health
OTHER
Responsible Party
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Principal Investigators
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Ali Keramati, MD
Role: PRINCIPAL_INVESTIGATOR
Lankenau Heart Institute
Locations
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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
Countries
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References
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Liskov S, Olleik F, Jarrett H, Abramson S, Kowey P, Schaller RD, Vijayaraman P, Habibi M, Bansal S, Heimann M, Cox S, Keramati AR. Comparing Left Bundle Branch Area vs Right-Ventricular Septal Pacing in High-Degree Conduction Disease After Transcatheter Aortic Valve Replacement: Randomized Trial Study Protocol. CJC Open. 2024 May 18;6(9):1058-1065. doi: 10.1016/j.cjco.2024.05.006. eCollection 2024 Sep.
Other Identifiers
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E-22-5212
Identifier Type: -
Identifier Source: org_study_id