Complete Heart BlockNCT05541679
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)
A study testing Right ventricular septal pacing followed by left bundle branch area pacing and Left bundle branch area pacing followed by right ventricular septal pacing in people with Complete Heart Block and High Degree Second Degree Atrioventricular Block, run by Main Line Health at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy
- What is being tested?
- Right ventricular septal pacing followed by left bundle branch area pacing and Left bundle branch area pacing followed by right ventricular septal pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Dec 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Valley Health System
Ridgewood, New Jersey, 07450
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
About this study
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
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
- Being tested
- Right ventricular septal pacing followed by left bundle branch area pacing, Left bundle branch area pacing followed by right ventricular septal pacing
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right ventricular septal pacing followed by left bundle branch area pacingDevice
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 pacingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Device: Right ventricular septal pacing followed by left bundle branch area pacing |
| Group B | Experimental | Not described Receives: Device: Left bundle branch area pacing followed by right ventricular septal pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global longitudinal strain (GLS%)
Primary efficacy outcome
Measured: 9 months
Change in left ventricular ejection fraction (LVEF%)
Primary efficacy outcome
Measured: 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
Measured: 18 months
Secondary outcomes (17)
Adverse events related to device function
Measured: 18 months
Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)
Measured: 9 months
Functional capacity measured using the New York Heart Association functional classification (NYHA)
Measured: 9 months
Six minute walk test score
Measured: 9 months
Hospitalizations for heart failure
Measured: 18 months
Mortality
Measured: 18 months
Right ventricular global longitudinal strain (RVGLS%)
Measured: 9 months
Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)
Measured: 9 months
Interventricular mechanical delay (IVMD)
Measured: 9 months
Left ventricular end-systolic volume
Measured: 9 months
Left ventricular stroke volume
Measured: 9 months
Severity of tricuspid regurgitation
Measured: 18 months
Severity of mitral regurgitation
Measured: 18 months
Left bundle branch area pacing lead pacing threshold
Measured: 18 months
Left bundle branch area pacing lead sensed R wave amplitude
Measured: 18 months
Left bundle branch area pacing lead impedence
Measured: 18 months
Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start28 Dec 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complete Heart BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Main Line Health
- Sponsor type
- University, hospital or other
- Collaborators
- Sharpe-Strumia Research Foundation, Medtronic
- Responsible party
- Sponsor
- Investigators
- Ali Keramati, MD, Principal investigator, Lankenau Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541679
- Sponsor's protocol ID
- E-22-5212
- Status last verified
- Dec 2024
- First submitted
- 13 Sep 2022
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 39525828
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05541679
- Acronym / sponsor ID
- E-22-5212
- Conditions
- Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy, Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Main Line HealthUniversity, hospital or other
- Collaborators
- Sharpe-Strumia Research Foundation, Medtronic
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject has at least one of these conduction disturbances:
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right ventricular septal pacing followed by left bundle branch area pacingAll 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. | Device | Group A |
| Left bundle branch area pacing followed by right ventricular septal pacingAll 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. | Device | Group B |
Primary outcome
Change in global longitudinal strain (GLS%)
Time frame: 9 months
Primary efficacy outcome
Change in left ventricular ejection fraction (LVEF%)
Time frame: 9 months
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
Time frame: 18 months
Primary safety endpoint
17 secondary outcomes
Adverse events related to device function
Time frame: 18 months
Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)
Time frame: 9 months
Functional capacity measured using the New York Heart Association functional classification (NYHA)
Time frame: 9 months
Six minute walk test score
Time frame: 9 months
Hospitalizations for heart failure
Time frame: 18 months
Mortality
Time frame: 18 months
Right ventricular global longitudinal strain (RVGLS%)
Time frame: 9 months
Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)
Time frame: 9 months
Interventricular mechanical delay (IVMD)
Time frame: 9 months
Left ventricular end-systolic volume
Time frame: 9 months
Left ventricular stroke volume
Time frame: 9 months
Severity of tricuspid regurgitation
Time frame: 18 months
Severity of mitral regurgitation
Time frame: 18 months
Left bundle branch area pacing lead pacing threshold
Time frame: 18 months
Left bundle branch area pacing lead sensed R wave amplitude
Time frame: 18 months
Left bundle branch area pacing lead impedence
Time frame: 18 months
Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 39525828Liskov 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Keramati, MD principal investigator
Lankenau Heart Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right ventricular septal pacing followed by left bundle branch area pacing and Left bundle branch area pacing followed by right ventricular septal pacing in people with Complete Heart Block and High Degree Second Degree Atrioventricular Block, run by Main Line Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global longitudinal strain (GLS%) (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05541679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.