LBBAP vs RV Pacemaker for Heart Pacing Issues

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Systolic dysfunction, Myocardial infarction, Coronary artery disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a new pacemaker placement method called LBBAP. It aims to help patients with normal heart function but severe AV block. The goal is to see if this method can prevent heart weakening compared to other methods. Left bundle branch area pacing (LBBaP) is a relatively new approach for physiologic pacing, showing promise in improving cardiac function.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Left Bundle Branch Area Pacemaker (LBBAP) for heart pacing issues?

Research shows that Left Bundle Branch Area Pacing (LBBAP) can be more effective than Right Ventricular Pacing (RVP) for patients with heart rhythm problems, as it may improve heart function and reduce negative effects associated with RVP. ^{1 2 3 4 5}

Is Left Bundle Branch Area Pacing (LBBAP) safe for humans?

Research shows that Left Bundle Branch Area Pacing (LBBAP) is generally considered safe for humans, with studies indicating it as a feasible and safe option compared to Right Ventricular Pacing (RVP) for various heart conditions. ^{3 5 6 7 8}

How is the treatment Left Bundle Branch Area Pacing (LBBAP) different from other treatments for heart pacing issues?

Left Bundle Branch Area Pacing (LBBAP) is unique because it targets the heart's natural conduction system, potentially reducing mechanical dyssynchrony (uneven heart muscle contractions) more effectively than traditional right ventricular pacing. It offers a more physiological pacing strategy, which may lead to better heart function and outcomes compared to other pacing methods. ^{1 5 6 9 10}

Research Team

Eligibility Criteria

The Boston Pace Study is for adults over 18 with complete or high-grade AV block expected to need a lot of ventricular pacing, and who have a left ventricular ejection fraction (LVEF) of 50% or more. They must have had an echocardiogram in the last three months. People with past heart muscle issues, recent heart attacks, blocked arteries, serious valve problems, short life expectancy or pregnancy cannot join.

Inclusion Criteria

I have a severe heart block that requires frequent pacing.

Left ventricular ejection fraction of 50% or more

Echocardiogram within the last 3 months

Exclusion Criteria

My heart's pumping ability is below normal.

I have blocked arteries in my heart.

I have had a heart attack before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Left Bundle Branch Area Pacing or Right Ventricular Pacing to assess efficacy, safety, and success rate

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment to evaluate the occurrence of pacing induced cardiomyopathy

12 weeks

Treatment Details

Interventions

• Left Bundle Branch Area Pacemaker (Pacemaker)
• Right Ventricular Pacemaker (Pacemaker)

Trial Overview This study tests two types of pacemakers: Left Bundle Branch Area Pacemaker (LBBAP), which is newer and might prevent heart muscle problems caused by pacing; and Right Ventricular Pacemaker (RVP), the traditional option. The goal is to see if LBBAP can be a better standard for patients needing frequent ventricular pacing.

Participant Groups

Group I: Left Bundle Branch Area Pacing Experimental Treatment 1 Intervention

Group II: Right Ventricular Pacing Active Control 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

In a study of 491 patients undergoing cardiac resynchronization therapy (CRT), left bundle branch area pacing (LBBAP) showed a lower rate of heart failure hospitalization and all-cause death compared to biventricular pacing (BVP), although the difference was not statistically significant.

After a median follow-up of 31 months, LBBAP demonstrated similar morbidity and mortality outcomes to BVP, suggesting it is a viable alternative for patients needing CRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Bundle Branch Area Pacing versus Biventricular Pacing for Cardiac Resynchronization Therapy on Morbidity and Mortality. Liang, Y., Xiao, Z., Liu, X., et al.[2022]

Left bundle branch area pacing (LBBAP) successfully improved cardiac function in patients with left bundle branch block (LBBB), achieving a success rate of 77.8% and significantly reducing QRS duration in both groups with left ventricular ejection fraction (LVEF) >35% and ≤35%.

Patients with LVEF >35% experienced better clinical outcomes, including a lower incidence of heart failure hospitalizations and mortality, suggesting that LBBAP is particularly effective in preventing cardiac function deterioration in early-stage heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Permanent Left Bundle Branch Area Pacing in Patients With Left Bundle Branch Block and Left Ventricular Ejection Fraction >35 vs. ≤35. Jiang, Z., Wu, T., Wu, Y., et al.[2022]

In a study of 903 patients with atrioventricular block, left bundle branch area pacing (LBBAP) was found to significantly lower the risk of all-cause mortality and heart failure hospitalization compared to right ventricular pacing (RVP), indicating its superior safety and effectiveness.

LBBAP also reduced the risk of recurrent unexplained syncope and improved left ventricular systolic synchrony, suggesting it may enhance heart function compared to traditional pacing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Bundle Branch Area Pacing versus Right Ventricular Pacing in Patients with Atrioventricular Block: An Observational Cohort Study. Chen, Z., Xu, Y., Jiang, L., et al.[2023]

Left bundle branch area pacing (LBBAP) significantly reduced QRS duration and improved left ventricular dyssynchrony in patients with left bundle branch block, suggesting it may enhance cardiac function compared to conventional right ventricular pacing (RVP).

In a study of 19 patients undergoing LBBAP and 14 patients undergoing RVP, LBBAP showed no adverse effects in those with preserved systolic function, while two patients with preserved function who received RVP developed heart failure, indicating a potential safety advantage of LBBAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Experience of Patients with left Bundle Branch Block Corrected through Left Bundle Branch Area Pacing Compared with Conventional Right Ventricular Pacing: A Single-Center Retrospective Study. Tung, CC., Liang, HY., Lai, YC., et al.[2023]

Left Bundle Branch Area Pacing (LBBAP) significantly reduces the risk of heart failure hospitalizations, all-cause mortality, and atrial fibrillation compared to Right Ventricular Pacing (RVP), based on a systematic review of 25 trials involving 4250 patients.

LBBAP also improves ventricular electrical and mechanical synchrony, with shorter QRS duration and better pacing parameters, while showing no difference in lead-related complications compared to RVP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of left bundle branch area pacing compared with right ventricular pacing in patients with bradyarrhythmia and conduction system disorders: Systematic review and meta-analysis. Leventopoulos, G., Travlos, CK., Aronis, KN., et al.[2023]

In a study comparing 39 patients with left bundle branch area pacing (LBBAP) to 42 patients with right ventricular septal pacing (RVSP), LBBAP was found to significantly reduce mechanical dyssynchrony, as indicated by smaller phase analysis parameters and regional wall motion analysis results.

LBBAP achieved similar phase and wall motion analysis parameters to those of healthy controls, suggesting it provides more physiological ventricular activation compared to RVSP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing cardiac mechanical dyssynchrony in left bundle branch area pacing and right ventricular septal pacing using myocardial perfusion scintigraphy in the acute phase of pacemaker implantation. Miyajima, K., Urushida, T., Tamura, T., et al.[2022]

Left bundle branch area pacing (LBBAP) was successfully performed in 90.9% of the 33 patients with atrioventricular block, demonstrating its feasibility as a new pacing approach.

LBBAP resulted in a stable pacing threshold and a significant reduction in QRS duration, indicating improved cardiac function and synchronization, with only one minor complication reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Permanent left bundle branch area pacing for atrioventricular block: Feasibility, safety, and acute effect. Li, X., Li, H., Ma, W., et al.[2020]

Left bundle branch area pacing (LBBAP) is both feasible and safe for patients with congenital heart disease (CHD), achieving acute success in all 13 CHD patients studied, similar to the 96% success rate in non-CHD patients.

Procedural times and lead parameters were comparable between CHD and non-CHD patients, indicating that LBBAP can be effectively performed in patients with complex heart anatomies without significant complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left bundle branch area pacing in congenital heart disease. O'Connor, M., Riad, O., Shi, R., et al.[2023]

A right-sided approach for left bundle branch area pacing (LBBAP) was successfully performed in a heart failure patient using a modified delivery sheath, demonstrating that LBBAP can be adapted for right-sided implantation.

This case highlights the feasibility of LBBAP in patients with anatomical challenges, such as a persistent left superior vena cava, and suggests that with proper modifications, effective pacing can be achieved with stable parameters in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right-sided approach to left bundle branch area pacing combined with atrioventricular node ablation in a patient with persistent left superior vena cava and left bundle branch block: a case report. Prolič Kalinšek, T., Žižek, D.[2022]

Left bundle branch area pacing (LBBaP) is a new and effective pacing strategy that can correct left bundle branch block (LBBB) and improve cardiac electrical synchronization, showing a high overall success rate.

While LBBaP required longer operative and X-ray exposure times compared to conventional right ventricular pacing (RVP), it did not significantly widen the QRS complex, indicating a safer profile for patients with LBBB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate clinical outcomes of left bundle branch area pacing vs conventional right ventricular pacing. Zhang, J., Wang, Z., Cheng, L., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Left Bundle Branch Area Pacing versus Biventricular Pacing for Cardiac Resynchronization Therapy on Morbidity and Mortality. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Permanent Left Bundle Branch Area Pacing in Patients With Left Bundle Branch Block and Left Ventricular Ejection Fraction >35 vs. ≤35. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Left Bundle Branch Area Pacing versus Right Ventricular Pacing in Patients with Atrioventricular Block: An Observational Cohort Study. [2023]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Early Experience of Patients with left Bundle Branch Block Corrected through Left Bundle Branch Area Pacing Compared with Conventional Right Ventricular Pacing: A Single-Center Retrospective Study. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and efficacy of left bundle branch area pacing compared with right ventricular pacing in patients with bradyarrhythmia and conduction system disorders: Systematic review and meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Assessing cardiac mechanical dyssynchrony in left bundle branch area pacing and right ventricular septal pacing using myocardial perfusion scintigraphy in the acute phase of pacemaker implantation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Permanent left bundle branch area pacing for atrioventricular block: Feasibility, safety, and acute effect. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Left bundle branch area pacing in congenital heart disease. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Right-sided approach to left bundle branch area pacing combined with atrioventricular node ablation in a patient with persistent left superior vena cava and left bundle branch block: a case report. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Immediate clinical outcomes of left bundle branch area pacing vs conventional right ventricular pacing. [2021]