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)
Primary Purpose
Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Right ventricular septal pacing followed by left bundle branch area pacing
Left bundle branch area pacing followed by right ventricular septal pacing
Sponsored by
About this trial
This is an interventional treatment trial for Complete Heart Block
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 two 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%
- 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 ≤ 50
- 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
Sites / Locations
- Lankenau Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Outcomes
Primary Outcome Measures
Change in global longitudinal strain (GLS%)
Primary efficacy outcome
Change in left ventricular ejection fraction (LVEF%)
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
Primary safety endpoint
Secondary Outcome Measures
Adverse events related to device function
Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)
Functional capacity measured using the New York Heart Association functional classification (NYHA)
Six minute walk test score
Hospitalizations for heart failure
Mortality
Right ventricular global longitudinal strain (RVGLS%)
Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)
Interventricular mechanical delay (IVMD)
Left ventricular end-systolic volume
Left ventricular stroke volume
Severity of tricuspid regurgitation
Severity of mitral regurgitation
Left bundle branch area pacing lead pacing threshold
Left bundle branch area pacing lead sensed R wave amplitude
Left bundle branch area pacing lead impedence
Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration
Full Information
NCT ID
NCT05541679
First Posted
September 13, 2022
Last Updated
February 20, 2023
Sponsor
Main Line Health
Collaborators
Medtronic, Sharpe-Strumia Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05541679
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Main Line Health
Collaborators
Medtronic, Sharpe-Strumia Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy, Aortic Valve Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Right ventricular septal pacing followed by left bundle branch area pacing
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Left bundle branch area pacing followed by right ventricular septal pacing
Intervention Description
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 Outcome Measure Information:
Title
Change in global longitudinal strain (GLS%)
Description
Primary efficacy outcome
Time Frame
9 months
Title
Change in left ventricular ejection fraction (LVEF%)
Description
Primary efficacy outcome
Time Frame
9 months
Title
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
Description
Primary safety endpoint
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Adverse events related to device function
Time Frame
18 months
Title
Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)
Time Frame
9 months
Title
Functional capacity measured using the New York Heart Association functional classification (NYHA)
Time Frame
9 months
Title
Six minute walk test score
Time Frame
9 months
Title
Hospitalizations for heart failure
Time Frame
18 months
Title
Mortality
Time Frame
18 months
Title
Right ventricular global longitudinal strain (RVGLS%)
Time Frame
9 months
Title
Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)
Time Frame
9 months
Title
Interventricular mechanical delay (IVMD)
Time Frame
9 months
Title
Left ventricular end-systolic volume
Time Frame
9 months
Title
Left ventricular stroke volume
Time Frame
9 months
Title
Severity of tricuspid regurgitation
Time Frame
18 months
Title
Severity of mitral regurgitation
Time Frame
18 months
Title
Left bundle branch area pacing lead pacing threshold
Time Frame
18 months
Title
Left bundle branch area pacing lead sensed R wave amplitude
Time Frame
18 months
Title
Left bundle branch area pacing lead impedence
Time Frame
18 months
Title
Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 two 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%
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 ≤ 50
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Keramati, MD
Phone
484-476-1000
Email
keramatia@mlhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Keramati, MD
Organizational Affiliation
Lankenau Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Keramati, MD
First Name & Middle Initial & Last Name & Degree
Steven Liskov, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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)
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