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)

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05541679
• Other study ID #: E-22-5212
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Main Line Health
• Contact: Ali Keramati, MD
• Phone: 484-476-1000
• Email: keramatia[@]mlhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Atrioventricular Block
• Cardiomyopathies
• Complete Heart Block
• Heart Block
• High Degree Second Degree Atrioventricular Block

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Valley Health System	Ridgewood	New Jersey
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Main Line Health	Medtronic, Sharpe-Strumia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

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