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Active, Not Recruiting

NCT Number: 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)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kansas City Heart Rhythm Institute, Overland Park, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in global longitudinal strain (GLS%)

    Time frame: 9 months

    Primary efficacy outcome

  2. Change in left ventricular ejection fraction (LVEF%)

    Time frame: 9 months

    Primary efficacy outcome

  3. 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

  1. Adverse events related to device function

    Time frame: 18 months

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

    Time frame: 9 months

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

    Time frame: 9 months

  4. Six minute walk test score

    Time frame: 9 months

  5. Hospitalizations for heart failure

    Time frame: 18 months

  6. Mortality

    Time frame: 18 months

  7. Right ventricular global longitudinal strain (RVGLS%)

    Time frame: 9 months

  8. Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)

    Time frame: 9 months

  9. Interventricular mechanical delay (IVMD)

    Time frame: 9 months

  10. Left ventricular end-systolic volume

    Time frame: 9 months

  11. Left ventricular stroke volume

    Time frame: 9 months

  12. Severity of tricuspid regurgitation

    Time frame: 18 months

  13. Severity of mitral regurgitation

    Time frame: 18 months

  14. Left bundle branch area pacing lead pacing threshold

    Time frame: 18 months

  15. Left bundle branch area pacing lead sensed R wave amplitude

    Time frame: 18 months

  16. Left bundle branch area pacing lead impedence

    Time frame: 18 months

  17. Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Main Line Health

Other

Collaborators

  • Medtronic
  • Sharpe-Strumia Research Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2022
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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