Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement

Main Line Health4 sites in 1 country46 target enrollmentDecember 28, 2022

ConditionsComplete Heart Block High Degree Second Degree Atrioventricular Block Pacemaker-Induced Cardiomyopathy Aortic Valve Stenosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Complete Heart Block
Sponsor: Main Line Health
Enrollment: 46
Locations: 4
Primary Endpoint: Change in left ventricular ejection fraction (LVEF%)
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 28, 2022

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Main Line Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

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

Outcomes

Primary Outcomes

Change in left ventricular ejection fraction (LVEF%)

Time Frame: 9 months

Primary efficacy outcome

Change in global longitudinal strain (GLS%)

Time Frame: 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

Time Frame: 18 months

Primary safety endpoint

Secondary Outcomes

Left bundle branch area pacing lead impedence(18 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)
Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration(9 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 ventricular end-systolic volume(9 months)
Six minute walk test score(9 months)
Interventricular mechanical delay (IVMD)(9 months)
Left ventricular stroke volume(9 months)