- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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)
January 29, 2024 updated by: Main Line Health
Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali Keramati, MD
- Phone Number: 484-476-1000
- Email: keramatia@mlhs.org
Study Locations
-
-
Kansas
-
Overland Park, Kansas, United States, 66211
- Recruiting
- Kansas City Heart Rhythm Institute
-
Contact:
- Krishna Pothineni, MD
-
-
New Jersey
-
Ridgewood, New Jersey, United States, 07450
- Recruiting
- Valley Health System
-
Contact:
- Mohammadali Habibi, MD
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Hospital of the University of Pennsylvania
-
Contact:
- Robert Schaller, DO
-
Wynnewood, Pennsylvania, United States, 19096
- Recruiting
- Lankenau Medical Center
-
Contact:
- Ali Keramati, MD
-
Sub-Investigator:
- Steven Liskov, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
|
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.
|
Experimental: Group B
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in global longitudinal strain (GLS%)
Time Frame: 9 months
|
Primary efficacy outcome
|
9 months
|
Change in left ventricular ejection fraction (LVEF%)
Time Frame: 9 months
|
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
Time Frame: 18 months
|
Primary safety endpoint
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 18 months
|
18 months
|
Adverse events related to device function
Time Frame: 18 months
|
18 months
|
Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)
Time Frame: 9 months
|
9 months
|
Functional capacity measured using the New York Heart Association functional classification (NYHA)
Time Frame: 9 months
|
9 months
|
Six minute walk test score
Time Frame: 9 months
|
9 months
|
Hospitalizations for heart failure
Time Frame: 18 months
|
18 months
|
Right ventricular global longitudinal strain (RVGLS%)
Time Frame: 9 months
|
9 months
|
Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)
Time Frame: 9 months
|
9 months
|
Interventricular mechanical delay (IVMD)
Time Frame: 9 months
|
9 months
|
Left ventricular end-systolic volume
Time Frame: 9 months
|
9 months
|
Left ventricular stroke volume
Time Frame: 9 months
|
9 months
|
Severity of tricuspid regurgitation
Time Frame: 18 months
|
18 months
|
Severity of mitral regurgitation
Time Frame: 18 months
|
18 months
|
Left bundle branch area pacing lead pacing threshold
Time Frame: 18 months
|
18 months
|
Left bundle branch area pacing lead sensed R wave amplitude
Time Frame: 18 months
|
18 months
|
Left bundle branch area pacing lead impedence
Time Frame: 18 months
|
18 months
|
Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali Keramati, MD, Lankenau Heart Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2022
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
September 13, 2022
First Submitted That Met QC Criteria
September 13, 2022
First Posted (Actual)
September 15, 2022
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-22-5212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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