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Active, not recruitingNCT05541679Updated Dec 10, 2024

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)

An interventional study of Right ventricular septal pacing followed by left bundle branch area pacing and Left bundle branch area pacing followed by right ventricular septal pacing in Complete Heart Block, High Degree Second Degree Atrioventricular Block and Pacemaker-Induced Cardiomyopathy, sponsored by Main Line Health. Active, not recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Main Line Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Complete Heart Block
  • High Degree Second Degree Atrioventricular Block
  • Pacemaker-Induced Cardiomyopathy
  • Aortic Valve Stenosis
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 46 is close to the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Main Line Health is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Group A

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

  • Experimental
    Group B

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

Interventions

  • DeviceRight 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.

  • DeviceLeft 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.

06

What researchers measure

Primary outcomes

  1. Change in global longitudinal strain (GLS%)

    Primary efficacy outcome

    Time frame: 9 months

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

    Primary efficacy outcome

    Time frame: 9 months

  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

    Primary safety endpoint

    Time frame: 18 months

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

07

Study locations

4 sites
  • Kansas City Heart Rhythm Institute
    Overland Park, Kansas 66211, United States
  • Valley Health System
    Ridgewood, New Jersey 07450, United States
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Lankenau Medical Center
    Wynnewood, Pennsylvania 19096, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05541679
Lead sponsor
Main Line Health
Collaborators
Sharpe-Strumia Research Foundation, Medtronic
Responsible party
Sponsor
First posted
Sep 15, 2022
Start date
Dec 28, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 10, 2024

Study contacts

Ali Keramati, MD
principal investigator · Lankenau Heart Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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