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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people with heart failure whose previous treatment, cardiac resynchronization therapy (CRT), was ineffective. Researchers are testing whether placing a new pacing lead in a different area, known as Left Bundle Branch Area Pacing (LBBAP), can enhance heart function and alleviate symptoms. The trial also uses MRI scans to evaluate the effectiveness of this approach. It targets individuals who received CRT over a year ago but have not experienced improvements in heart symptoms or function. As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment options.

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 prior data suggests that this pacing technique is safe for heart failure patients?

Research has shown that Left Bundle Branch Area Pacing (LBBAP) safely treats heart failure and other heart rhythm issues. One study found that LBBAP is easy to use and effective without frequent adjustments. Another study demonstrated that LBBAP often succeeds and has low complication rates, even when performed by less experienced doctors. These findings suggest that patients generally tolerate LBBAP well, making it a promising option for those not responding to current heart failure treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Left Bundle Branch Area Pacing (LBBAP) for heart failure patients who haven't responded to traditional Cardiac Resynchronization Therapy (CRT) because it targets a more precise area of the heart's electrical system. This approach aims to improve the heart's pumping efficiency by directly pacing the left bundle branch, potentially leading to better outcomes for those who didn't benefit from standard CRT. Additionally, the trial is exploring the use of cardiac MRI to assess heart function in patients with implanted devices, which could offer a non-invasive way to monitor progress and tailor treatments more effectively.

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

This trial will investigate Left Bundle Branch Area Pacing (LBBAP) for patients with heart failure who did not respond to standard cardiac resynchronization therapy. Studies have shown that LBBAP can effectively improve heart function in these patients. This technique involves placing a small wire in a specific part of the heart to help control the heartbeat. Research indicates that LBBAP is often successful and safe, even when performed by doctors new to the procedure. Initial findings suggest that this method can aid patients who did not benefit from the usual treatment designed to improve heart rhythm and function. This approach could potentially reduce heart failure symptoms by better coordinating the heart's pumping action. ^{1 2 3 6 7}

Who Is on the Research Team?

Selma D Carlson, MD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33602393/

Left Bundle Branch Area Pacing for Cardiac ... Objectives: The aim of this study was to assess the feasibility and outcomes of left bundle branch area pacing (LBBAP) in patients eligible for cardiac ...

2. 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 ...

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

Real-world adoption of left bundle branch area pacing LBBAP is routinely adopted for bradycardia and heart failure indication, with high success and acceptable complication rates, even when performed by less ...

4. academic.oup.com academic.oup.com/europace/article/27/10/euaf154/8215864

Left bundle branch pacing in patients with structural heart ... Novel intraprocedural methods of performing left bundle branch pacing in heart failure patients as well as optimal programming post-implant are highlighted.

5. aerjournal.com aerjournal.com/articles/emerging-role-left-bundle-branch-area-pacing-cardiac-resynchronisation-therapy?language_content_entity=en

The Emerging Role of Left Bundle Branch Area Pacing ... Cardiac resynchronisation therapy (CRT) reduces the risk of heart failure-related hospitalisations and all-cause mortality, as well as improving ...

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(23)02203-8/fulltext

LB-456088-1 LEFT BUNDLE BRANCH AREA PACING ... The aim of this study was to compare the clinical outcomes between BVP and LBBAP among patients undergoing CRT.

7. academic.oup.com academic.oup.com/europace/article/27/Supplement_1/euaf085.593/8141427

Outcomes of the left bundle branch area pacing as a first-line ... CRT utilizing left bundle branch area pacing may be used as a first line option in patients with heart failure and LBBB with high success rate and favorable ...