LBBAP vs RV Pacemaker for Heart Pacing Issues

Not currently recruiting at 1 trial location

Overseen By Chee Yuan Ng, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of pacemakers to determine which works better for individuals with heart pacing issues. One group will receive a Left Bundle Branch Area Pacemaker, a new technique believed to help avoid heart problems caused by traditional pacing methods. The other group will use the regular Right Ventricular Pacemaker for comparison. The trial seeks participants with heart block (a type of heart rhythm problem) who have recently had a heart ultrasound showing good heart function. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially benefit from innovative pacing techniques.

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 prior data suggests that these pacing techniques are safe for heart patients?

Research has shown that Left Bundle Branch Area Pacing (LBBAP) is generally safe for individuals needing heart pacing. Studies have found that LBBAP can reduce the risk of heart failure, which sometimes occurs with the conventional method of pacing the right side of the heart. This is promising because right-side pacing can lead to issues like heart muscle weakening and irregular heartbeats.

In studies that monitored participants for up to two years, most did not experience serious side effects from LBBAP. Overall, these findings suggest that LBBAP is a safe option for heart pacing, though further research is needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which typically involves right ventricular pacing for heart pacing issues, the Left Bundle Branch Area Pacemaker (LBBAP) targets a different part of the heart, offering a more physiological approach to heart pacing. This treatment aims to mimic natural heart conduction more closely, potentially leading to better heart function and fewer complications over time. Researchers are excited about LBBAP because it could improve the synchronization of heartbeats, which might enhance patients' quality of life and reduce the risk of heart failure compared to traditional pacemakers.

What evidence suggests that this trial's treatments could be effective for heart pacing issues?

This trial will compare Left Bundle Branch Area Pacing (LBBAP) with Right Ventricular Pacing (RVP) for heart pacing issues. Studies have shown that LBBAP can lower the risk of heart failure compared to RVP. Research suggests that LBBAP offers a promising treatment for heart rhythm problems and helps prevent heart muscle damage. Long-term results indicate that LBBAP improves heart function and reduces complications. Although widely used, more real-world data is needed to fully understand its effectiveness. However, current evidence supports LBBAP as a potentially better option for heart issues related to pacing. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Left Bundle Branch Area Pacemaker
• Right Ventricular 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.

How Is the Trial Designed?

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

Group II: Right Ventricular Pacing Active Control 1 Intervention

Left Bundle Branch Area Pacemaker is already approved in United States for the following indications:

Approved in United States as INGEVITY+ Pacing Lead for:

• Symptomatic bradycardia
• Conduction system pacing of the left bundle branch area

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

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

Published Research Related to This Trial

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]

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) 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]

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) 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]

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]

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]

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]

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]

Citations

1. academic.oup.com academic.oup.com/europace/article/27/8/euaf181/8242754

Two-year outcomes of left bundle branch area pacing versus ... This registry-based trial compared left bundle branch area pacing (LBBAP) with RVP in patients younger than 65 years. Methods and results. Using ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12160678/

Comparison of Clinical Outcomes Between Left Bundle ... Left bundle branch area pacing (LBBAP) has been shown to reduce the risk of pacing‐facilitated heart failure (HF) compared to right ventricular pacing (RVP).

3. sciencedirect.com sciencedirect.com/science/article/pii/S0167527324015018

Real-world adoption of left bundle branch area pacing Left bundle branch area pacing (LBBAP) is increasingly used for treating bradycardia and heart failure. However, real-world data are limited ...

4. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)03318-6/abstract

Long-term outcomes of left bundle branch area pacing ... The purpose of this study was to investigate whether left bundle branch area pacing (LBBAP) improves long-term clinical results compared with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07069738

NCT07069738 | Safety and Effectiveness of Left Bundle ... This study will compare two different methods to pace the heart to treat heart failure including: The current standard method of implanting a pacing lead in ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1547527125026335

Two-year follow-up of the safety and clinical outcomes ... Two-year follow-up of the safety and clinical outcomes of stylet-driven leads for left bundle branch area pacing compared with right ventricular ...