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

Recruiting in Palo Alto (17 mi)

Overseen by Selma D Carlson, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Cancer, MRI issues, others

No Placebo Group

Approved in 2 Jurisdictions

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Minneapolis VA Health Care System, Minneapolis, MN Minneapolis, MN

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

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] Left bundle branch area pacing (LBBAP) was reported to improve cardiac function by correcting complete left bundle branch block (CLBBB). Our study aimed to compare the efficacy of LBBAP and biventricular pacing (BIVP) in heart failure patients with CLBBB.

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] The present study aimed to compare the effects of left bundle branch area pacing (LBBAP) on cardiac function and clinical outcomes in patients with left bundle branch block (LBBB) and left ventricular ejection fraction (LVEF) >35 vs. ≤35%.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility and safety of left bundle branch area pacing-cardiac resynchronization therapy in elderly patients. [2023] Left bundle branch area pacing (LBBAP) is an emerging technique to achieve cardiac resynchronization therapy (CRT), but its feasibility and safety in elderly patients with heart failure with reduced ejection fraction and left bundle branch block is hardly investigated.

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

Left bundle branch area pacing prevents pacing induced cardiomyopathy in long-term observation. [2023] Left bundle branch area pacing (LBBAP) is one of the methods to deliver conduction system pacing which potentially avoids the negative impact of conventional right ventricular pacing.

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

Immediate clinical outcomes of left bundle branch area pacing vs conventional right ventricular pacing. [2021] Left bundle branch area pacing (LBBaP) is a new physiological pacing strategy that produces comparable clinical effects to His bundle pacing (HBP).

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

The Implantation of Left Bundle Branch Area Pacing in Patients with and without Bundle Branch Block. [2021] To investigate the clinical safety and electrocardiogram (ECG) characteristics in patients with left bundle branch area pacing (LBBAP).

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] Left bundle branch area pacing (LBBAP) is a physiological pacing method for treatment of atrioventricular block. However, there is a need for a new convenient and safe method for performing left bundle branch pacing (LBBP) and to confirm left conduction system capture.

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

Durability of left bundle branch area pacing. [2022] Left bundle branch area pacing (LBBAP) is a form of conduction system pacing. Long-term data on the safety and performance of LBBAP 1 year postdevice implantation has not been well described.

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] To evaluate the efficacy and safety of left bundle branch area pacing (LBBaP) in patients with heart failure and left bundle branch block (LBBB), and to compare the clinical effects with traditional cardiac resynchronization therapy (CRT).

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

Contrast-enhanced image-guided lead deployment for left bundle branch pacing. [2022] Left bundle branch pacing (LBBP) is a novel conduction system pacing modality, but pacing lead deployment remains challenging.

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] Left bundle branch area pacing (LBBAP) aims to capture the cardiac conduction system in area of the left bundle branch. Currently, LBBAP is mainly performed using lumen-less pacing leads (LLLs) with preshaped sheath. However, the data on LBBAP with stylet-driven leads (SDLs) without sheath is limited.