Left Bundle Branch Area PacingNCT05869500
The Boston Pace Study
A study testing Left Bundle Branch Area Pacemaker and Right Ventricular Pacemaker in people with Left Bundle Branch Area Pacing, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
Right ventricular (RV) pacing can cause left ventricular systolic dysfunction in 10- 20% of patients. Biventricular pacing had previously been shown to prevent left ventricular systolic dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Bundle Branch Area Pacing
- What is being tested?
- Left Bundle Branch Area Pacemaker and Right Ventricular Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2023to 31 Aug 2026
- 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
- Age >18
- Patients with complete AV block, high-grade AV block with an anticipated ventricular pacing rate of more than 40%
- Left ventricular ejection fraction of 50% or more.
- Echocardiogram within the last 3 months
Who cannot join
- History of systolic dysfunction with LV EF of less than 50%
- Prior myocardial infarction
- Obstructive coronary artery disease
- Severe valvular dysfunction
- Life expectancy of less than a year
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Left Bundle Area Pacing Vs. Right Ventricular Pacing in Patients With Normal Left Ventricular Function -The Boston Pace Study
Right ventricular (RV) pacing can cause left ventricular systolic dysfunction in 10- 20% of patients. Biventricular pacing had previously been shown to prevent left ventricular systolic dysfunction. However, implantation of coronary sinus lead increases procedural risk and can be limited by higher threshold and phrenic nerve capture. HIS pacing has been evaluated as an alternative pacing strategy, but its routine use was limited by difficulty of the procedure, success rate and high pacing threshold.
Left bundle branch area pacing (LBBAP) is a promising physiologic pacing technique that has been proposed as a pacing strategy to prevent pacing induced cardiomyopathy and for treatment of desynchrony in heart failure. LBBAP has been adopted widely and performed routinely on patients with AV block. Currently, it is up to the discretion of the proceduralist whether LBBAP is performed given that there is lack of evidence to guide pacing strategies.
Read the detailed description
This pilot trial is a feasibility study that will assess for efficacy, safety and success rate of left bundle branch area pacing. The study will also examine the recruitment rate at 2 major tertiary hospitals.
The study will examine if the use of LBBAP can prevent the occurrence of pacing induced cardiomyopathy (PICM) compared to RV pacing among patients with normal left ventricular function and high-grade AV block.
The investigators hypothesize that the rate of pacing induced cardiomyopathy is lower with LBBAP compared to RV pacing in patients with normal left ventricular function requiring high burden of RV pacing.
- Conditions
- Left Bundle Branch Area Pacing
- Being tested
- Left Bundle Branch Area Pacemaker, Right Ventricular Pacemaker
- Keywords
- left bundle branch, left bundle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Bundle Branch Area PacemakerDevice
Implantation of Medtronic 3830 lead for left bundle branch area pacing
Right Ventricular PacemakerDevice
Implantation of a conventional right ventricular pacemaker lead
| Study group | Role | What they receive |
|---|---|---|
| Left Bundle Branch Area Pacing | Experimental | Not described Receives: Device: Left Bundle Branch Area Pacemaker |
| Right Ventricular Pacing | Active comparator | Not described Receives: Device: Right Ventricular Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular ejection fraction (LVEF)
Measured: 12 months
Change in left ventricular end systolic volume (LVESV)
Measured: 12 months
Secondary outcomes (18)
Success rate of LBBAP
Measured: 30 days
All-cause mortality
Measured: 12 months
Cardiovascular mortality
Measured: 12 months
Rate of heart failure related visit: defined as heart failure hospitalization or emergency room visit or urgent visit requiring intravenous heart failure therapy
Measured: 12 months
Number of participants with upgrade to cardiac resynchronization therapy
Measured: 12 months
New York Heart Association Class I-IV (IV is worst)
Measured: 12 months
Number of participants with occurrence of moderate or severe tricuspid regurgitation on echocardiogram
Measured: 12 months
Number of participants with occurrence of moderate or severe mitral regurgitation on echocardiogram
Measured: 12 months
Number of participants with new onset atrial fibrillation
Measured: 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (score of 8-40)
Measured: 12 months
Paced QRS duration on 12 lead EKG
Measured: Evaluated at 1 day, 30 days and 12 months
Pacing percentage
Measured: 12 months
Complication rate including pneumothorax, cardiac tamponade, infection, and lead revision
Measured: 12 months
Procedure time
Measured: 1 day
Fluoroscopy time
Measured: 1 day
Pacing capture threshold (V)
Measured: 12 months
R wave amplitude (mV)
Measured: 12 months
RV lead impedance (ohms)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 May 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Bundle Branch Area PacingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Shaan Khurshid, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869500
- Sponsor's protocol ID
- 2022P003143
- Status last verified
- Jul 2026
- First submitted
- 17 Apr 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Area Pacing Vs. Right Ventricular Pacing in Patients With Normal Left Ventricular Function -The Boston Pace Study
- ClinicalTrials.gov ID
- NCT05869500
- Acronym / sponsor ID
- 2022P003143
- Conditions
- Left Bundle Branch Area Pacing
- Keywords
- left bundle branch, left bundle
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 May 2023 (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.
Right ventricular (RV) pacing can cause left ventricular systolic dysfunction in 10- 20% of patients. Biventricular pacing had previously been shown to prevent left ventricular systolic dysfunction. However, implantation of coronary sinus lead increases procedural risk and can be limited by higher threshold and phrenic nerve capture. HIS pacing has been evaluated as an alternative pacing strategy, but its routine use was limited by difficulty of the procedure, success rate and high pacing threshold.
Left bundle branch area pacing (LBBAP) is a promising physiologic pacing technique that has been proposed as a pacing strategy to prevent pacing induced cardiomyopathy and for treatment of desynchrony in heart failure. LBBAP has been adopted widely and performed routinely on patients with AV block. Currently, it is up to the discretion of the proceduralist whether LBBAP is performed given that there is lack of evidence to guide pacing strategies.
Detailed description
This pilot trial is a feasibility study that will assess for efficacy, safety and success rate of left bundle branch area pacing. The study will also examine the recruitment rate at 2 major tertiary hospitals.
The study will examine if the use of LBBAP can prevent the occurrence of pacing induced cardiomyopathy (PICM) compared to RV pacing among patients with normal left ventricular function and high-grade AV block.
The investigators hypothesize that the rate of pacing induced cardiomyopathy is lower with LBBAP compared to RV pacing in patients with normal left ventricular function requiring high burden of RV pacing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Bundle Branch Area Pacing | Experimental | Device: Left Bundle Branch Area Pacemaker |
| Right Ventricular Pacing | Active comparator | Device: Right Ventricular Pacemaker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18
- Patients with complete AV block, high-grade AV block with an anticipated ventricular pacing rate of more than 40%
- Left ventricular ejection fraction of 50% or more.
- Echocardiogram within the last 3 months
Key exclusion criteria (6 listed)
- History of systolic dysfunction with LV EF of less than 50%
- Prior myocardial infarction
- Obstructive coronary artery disease
- Severe valvular dysfunction
- Life expectancy of less than a year
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 |
|---|---|---|
| Left Bundle Branch Area PacemakerImplantation of Medtronic 3830 lead for left bundle branch area pacing | Device | Left Bundle Branch Area Pacing |
| Right Ventricular PacemakerImplantation of a conventional right ventricular pacemaker lead | Device | Right Ventricular Pacing |
Primary outcome
Change in left ventricular ejection fraction (LVEF)
Time frame: 12 months
Change in left ventricular end systolic volume (LVESV)
Time frame: 12 months
18 secondary outcomes
Success rate of LBBAP
Time frame: 30 days
All-cause mortality
Time frame: 12 months
Cardiovascular mortality
Time frame: 12 months
Rate of heart failure related visit: defined as heart failure hospitalization or emergency room visit or urgent visit requiring intravenous heart failure therapy
Time frame: 12 months
Number of participants with upgrade to cardiac resynchronization therapy
Time frame: 12 months
New York Heart Association Class I-IV (IV is worst)
Time frame: 12 months
Number of participants with occurrence of moderate or severe tricuspid regurgitation on echocardiogram
Time frame: 12 months
Number of participants with occurrence of moderate or severe mitral regurgitation on echocardiogram
Time frame: 12 months
Number of participants with new onset atrial fibrillation
Time frame: 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (score of 8-40)
Time frame: 12 months
Paced QRS duration on 12 lead EKG
Time frame: Evaluated at 1 day, 30 days and 12 months
Pacing percentage
Time frame: 12 months
Complication rate including pneumothorax, cardiac tamponade, infection, and lead revision
Time frame: 12 months
Procedure time
Time frame: 1 day
Fluoroscopy time
Time frame: 1 day
Pacing capture threshold (V)
Time frame: 12 months
R wave amplitude (mV)
Time frame: 12 months
RV lead impedance (ohms)
Time frame: 12 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 13 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Bundle Branch Area Pacemaker and Right Ventricular Pacemaker in people with Left Bundle Branch Area Pacing, run by Massachusetts General Hospital at 2 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 4 inclusion and 6 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 left ventricular ejection fraction (LVEF) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.