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)

Not Applicable

Active, not recruiting

• Conditions: High Degree Second Degree Atrioventricular Block; Aortic Valve Stenosis; Complete Heart Block; Pacemaker-Induced Cardiomyopathy
• Interventions: Device: Left bundle branch area pacing followed by right ventricular septal pacing; Device: Right ventricular septal pacing followed by left bundle branch area pacing

• Registration Number: NCT05541679
• Lead Sponsor: Main Line Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-15
• Study Start: 2022-12-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Left bundle branch area pacing followed by right ventricular septal pacing	-
Group A	Right ventricular septal pacing followed by left bundle branch area pacing	-

Primary Outcome Measures

Name	Time	Method
Change in left ventricular ejection fraction (LVEF%)	9 months	Primary efficacy outcome
Change in global longitudinal strain (GLS%)	9 months	Primary efficacy outcome
Composite of left bundle branch area pacing lead septal myocardial or coronary artery perforation, lead dislodgment, and repeat procedures related to left bundle branch area lead implantation	18 months	Primary safety endpoint

Secondary Outcome Measures

Name	Time	Method
Left ventricular end-systolic volume	9 months
Adverse events related to device function	18 months
Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)	9 months
Right ventricular global longitudinal strain (RVGLS%)	9 months
Mortality	18 months
Severity of mitral regurgitation	18 months
Left bundle branch area pacing lead pacing threshold	18 months
Functional capacity measured using the New York Heart Association functional classification (NYHA)	9 months
Hospitalizations for heart failure	18 months
Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)	9 months
Severity of tricuspid regurgitation	18 months
Left bundle branch area pacing lead sensed R wave amplitude	18 months
Left bundle branch area pacing lead impedence	18 months
Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration	9 months
Six minute walk test score	9 months
Interventricular mechanical delay (IVMD)	9 months
Left ventricular stroke volume	9 months

Trial Locations

Locations (4)

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