Clinical trial NCT05541679: 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)
Official title: Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Complete Heart Block
High Degree Second Degree Atrioventricular Block
Pacemaker-Induced Cardiomyopathy
Aortic Valve Stenosis
Lead sponsor: Main Line Health
Sponsor class: OTHER
Collaborators: name: Sharpe-Strumia Research Foundation
name: Medtronic
First posted: 2022-09-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in global longitudinal strain (GLS%)
timeFrame: 9 months
measure: Change in left ventricular ejection fraction (LVEF%)
timeFrame: 9 months
measure: 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
timeFrame: 18 months
Secondary outcomes:
measure: Adverse events related to device function
timeFrame: 18 months
measure: Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)
timeFrame: 9 months
measure: Functional capacity measured using the New York Heart Association functional classification (NYHA)
timeFrame: 9 months
measure: Six minute walk test score
timeFrame: 9 months
measure: Hospitalizations for heart failure
timeFrame: 18 months
measure: Mortality
timeFrame: 18 months
measure: Right ventricular global longitudinal strain (RVGLS%)
timeFrame: 9 months
measure: Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)
timeFrame: 9 months
measure: Interventricular mechanical delay (IVMD)
timeFrame: 9 months
measure: Left ventricular end-systolic volume
timeFrame: 9 months
measure: Left ventricular stroke volume
timeFrame: 9 months
measure: Severity of tricuspid regurgitation
timeFrame: 18 months
measure: Severity of mitral regurgitation
timeFrame: 18 months
measure: Left bundle branch area pacing lead pacing threshold
timeFrame: 18 months
measure: Left bundle branch area pacing lead sensed R wave amplitude
timeFrame: 18 months
measure: Left bundle branch area pacing lead impedence
timeFrame: 18 months
measure: Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration
timeFrame: 9 months
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Ridgewood
country: United States
facility: Valley Health System
state: New Jersey
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
Study officials:
affiliation: Lankenau Heart Institute
name: Ali Keramati, MD
role: PRINCIPAL_INVESTIGATOR
References: