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)

NCT05541679 | Active Not Recruiting FDA Device

• 1 other identifier: E-22-5212
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Change in global longitudinal strain (GLS%)

  Primary efficacy outcome

  9 months

• Change in left ventricular ejection fraction (LVEF%)

  Primary efficacy outcome

  9 months

• 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 Outcomes (17)

• Adverse events related to device function

  18 months

• Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)

  9 months

• Functional capacity measured using the New York Heart Association functional classification (NYHA)

  9 months

• Six minute walk test score

  9 months

• Hospitalizations for heart failure

  18 months

Study Arms (2)

Group A

EXPERIMENTAL

Device: Right ventricular septal pacing followed by left bundle branch area pacing

Group B

EXPERIMENTAL

Device: Left bundle branch area pacing followed by right ventricular septal pacing

Interventions

Right ventricular septal pacing followed by left bundle branch area pacing DEVICE

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 A

Left bundle branch area pacing followed by right ventricular septal pacing DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Main Line Health: lead
• Sharpe-Strumia Research Foundation: collaborator
• Medtronic: collaborator

Study Sites (4)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Valley Health System

Ridgewood, New Jersey, 07450, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Related Publications (1)

• 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.

  PMID: 39525828 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Ali Keramati, MD

  Lankenau Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: December 28, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

US (4)