Left Bundle Branch Area Pacing for Heart Failure Non-Responders to Cardiac Resynchronization Therapy

Overseen By Selma D Carlson, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Cancer, MRI issues, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to investigate whether the investigators can improve heart function in patients with heart failure who have undergone cardiac resynchronization therapy, but have not had an improvement in their heart function at least one year after the procedure. The investigators will evaluate whether placing a new pacing lead (electrode) in a different part of the heart may increase heart function and decrease heart failure symptoms.

Do I need to stop my current medications for the trial?

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 Pacing for heart failure non-responders to Cardiac Resynchronization Therapy?

Research shows that Left Bundle Branch Area Pacing (LBBAP) can improve heart function in patients with heart failure by correcting issues with the heart's electrical system, similar to other pacing methods. It has been found to be effective in patients with specific heart conditions, like left bundle branch block, and can prevent negative effects seen with other pacing techniques. ^{1 2 3 4 5}

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

Research on Left Bundle Branch Area Pacing (LBBAP) suggests it is generally safe, but long-term safety data is limited. Studies have evaluated its safety in patients with heart failure and other conditions, indicating it is a feasible and emerging technique, though more research is needed to fully understand its long-term safety. ^{3 6 7 8 9}

How is left bundle branch area pacing different from other treatments for heart failure non-responders to cardiac resynchronization therapy?

Left bundle branch area pacing (LBBAP) is unique because it directly targets the heart's conduction system to improve heart function, unlike traditional biventricular pacing which stimulates the heart's ventricles. This approach may offer better synchronization of the heart's contractions, especially in patients with left bundle branch block, potentially leading to improved outcomes for those who do not respond to standard cardiac resynchronization therapy. ^{1 2 3 10 11}

Research Team

Selma D Carlson, MD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Eligibility Criteria

This trial is for veterans with heart failure who didn't get better after cardiac resynchronization therapy (CRT) at least a year ago. They should not have improved in symptoms, heart pumping function, or heart size reduction. It's not for those with weak immune systems, cancer patients on chemo, pregnant women, or anyone unable to follow the study plan.

Inclusion Criteria

I am a veteran who didn't improve after heart therapy over a year ago.

Exclusion Criteria

I am currently undergoing chemotherapy for cancer.

I am at high risk for infections from medical procedures.

Patients with weakened immune systems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of the left bundle branch area pacing electrode to improve cardiac function in CRT non-responders

6 months

Regular visits for monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment using echocardiography and cardiac MRI

6 months

Follow-up visits for imaging and assessment

Treatment Details

Interventions

• Left Bundle Branch Area Pacing

Trial Overview The study tests if placing a new pacing lead in a different part of the heart can help people whose hearts haven't responded to CRT. Participants will undergo an MRI and receive left bundle branch area pacing to see if it improves their heart function and reduces symptoms.

Participant Groups

Group I: LBBAP Experimental Treatment 1 Intervention

This arm will investigate improvement in cardiac function following placement of the LBBA pacing electrode in half the patients.

Group II: Cardiac MRI with devices Experimental Treatment 1 Intervention

This arm will investigate the feasibility of cardiac MRI to be used to measure cardiac function in patients with cardiac devices.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Left bundle branch area pacing (LBBAP) is a safe and effective method for correcting complete left bundle branch block (CLBBB) in heart failure patients, with no complications reported in the study of 10 patients.

LBBAP showed superior outcomes compared to biventricular pacing (BIVP), with a higher response rate (100% vs. 63.33%) and greater improvement in electrical synchrony, as indicated by a significantly larger decrease in QRS duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of left bundle branch area pacing compared with biventricular pacing in patients with heart failure: A matched case-control study. Wang, Y., Gu, K., Qian, Z., et al.[2021]

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) is a feasible and safe method for cardiac resynchronization therapy (CRT) in elderly patients (≥ 75 years), with a success rate of 92% in a study of 60 patients.

Both elderly and younger patients experienced significant improvements in heart function, as indicated by reduced QRS duration and increased left ventricular ejection fraction (LVEF), with low complication rates observed in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety of left bundle branch area pacing-cardiac resynchronization therapy in elderly patients. Grieco, D., Bressi, E., Sedláček, K., et al.[2023]

In a study of 151 patients with symptomatic bradycardia who received left bundle branch area pacing (LBBAP), none developed pacing-induced cardiomyopathy (PICM), indicating that LBBAP is a safe option for patients with preserved left ventricular ejection fraction (LVEF).

For patients with a baseline LVEF below 50%, LBBAP significantly improved heart function, with LVEF increasing from 41.4% to 45.6% and global longitudinal strain (GLS) improving from 12.9% to 15.5% over a median follow-up of 23 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left bundle branch area pacing prevents pacing induced cardiomyopathy in long-term observation. Bednarek, A., Kiełbasa, G., Moskal, P., 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]

Left bundle branch area pacing (LBBAP) is a safe and effective method for patients requiring ventricular pacing, showing no complications during implantation and stable pacing parameters over an average follow-up of 9.2 months.

Patients receiving LBBAP exhibited a right bundle branch block (RBBB) morphology on ECG with significantly shorter QRS duration and stimulus to peak left ventricular activation time compared to those paced at the right ventricular septum, indicating improved electrical activation of the heart.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implantation of Left Bundle Branch Area Pacing in Patients with and without Bundle Branch Block. Chen, TP., Shi, XJ., Lu, DY., et al.[2021]

A new method for selective left bundle branch pacing (LBBP) using continuous low output (2 V / 0.5 ms) was evaluated in 28 patients, showing a high rate of successful left bundle branch capture during the procedure.

The study found that an abrupt shortening of the stimulus-to-peak left ventricular activation time (S-peak LVAT) during low output pacing was highly sensitive (100%) for predicting effective pacing, indicating this method could enhance the safety and efficacy of LBBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the shortening of the stimulus-to-peak left ventricular activation time at continuous low output to confirm left bundle branch capture. Zhong, J., Zheng, N., Jiang, L.[2022]

Left bundle branch area pacing (LBBAP) is a safe and effective long-term pacing method for patients with bradycardia, showing stable pacing thresholds and no procedure-related complications over 12 months in a study of 65 patients.

Patients with pre-existing left bundle branch block experienced the most significant improvement, with a 24 ms narrowing of the paced QRS duration, indicating enhanced cardiac function with LBBAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability of left bundle branch area pacing. Mehta, NA., Saqi, B., Sabzwari, SRA., et al.[2022]

Left bundle branch area pacing (LBBaP) is a safe and effective method for resynchronizing heart function in patients with heart failure and left bundle branch block, showing significant improvements in heart function after 12 months.

Compared to traditional cardiac resynchronization therapy (CRT), LBBaP resulted in shorter operation and X-ray exposure times, and it achieved a narrower QRS complex more quickly, indicating better electrical synchronization of the heart.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac resynchronization performed by LBBaP-CRT in patients with cardiac insufficiency and left bundle branch block. Zu, L., Wang, Z., Hang, F., et al.[2021]

A visualization-enhanced technique for left bundle branch pacing (LBBP) implantation significantly reduced procedural time and fluoroscopy duration compared to the standard approach, with times of 66.76 minutes and 7.83 minutes respectively versus 85.46 minutes and 11.11 minutes.

The visualization technique also resulted in fewer lead deployment attempts and a higher success rate in recording left bundle branch potentials (79.3% vs 46.4%), indicating improved efficacy in achieving optimal lead placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced image-guided lead deployment for left bundle branch pacing. Liu, X., Niu, HX., Gu, M., et al.[2022]

Left bundle branch area pacing (LBBAP) using stylet-driven leads (SDLs) without a sheath was successfully performed in 23 out of 25 patients (92% success rate), demonstrating its feasibility and safety for treating bradycardia.

The pacing characteristics, including QRS duration and pacing thresholds, were comparable between SDL-LBBAP and lumen-less leads (LLLs), while showing significant advantages over right ventricular septal pacing (RVSP), indicating that SDLs could be a viable alternative to LLLs in LBBAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary experience of permanent left bundle branch area pacing using stylet-directed pacing lead without delivery sheath. Sun, Y., Yao, X., Zhou, X., et al.[2022]

References

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

The efficacy of left bundle branch area pacing compared with biventricular pacing in patients with heart failure: A matched case-control study. [2021]

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. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility and safety of left bundle branch area pacing-cardiac resynchronization therapy in elderly patients. [2023]

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

Left bundle branch area pacing prevents pacing induced cardiomyopathy in long-term observation. [2023]

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

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

6. Pakistan pubmed.ncbi.nlm.nih.gov

The Implantation of Left Bundle Branch Area Pacing in Patients with and without Bundle Branch Block. [2021]

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

Evaluation of the shortening of the stimulus-to-peak left ventricular activation time at continuous low output to confirm left bundle branch capture. [2022]

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

Durability of left bundle branch area pacing. [2022]

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

Cardiac resynchronization performed by LBBaP-CRT in patients with cardiac insufficiency and left bundle branch block. [2021]

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

Contrast-enhanced image-guided lead deployment for left bundle branch pacing. [2022]

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

Preliminary experience of permanent left bundle branch area pacing using stylet-directed pacing lead without delivery sheath. [2022]