His Bundle vs Biventricular Pacing for Heart Failure

Recruiting at 11 trial locations

Overseen By Merin Thomas

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Baylor College of Medicine

Must be taking: Heart failure therapy

Disqualifiers: Pregnancy, Coronary disease, Myocardial infarction, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated \>40% pacing who are already receiving current standard heart failure pharmacological therapy.

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

The trial protocol does not specify if you need to stop your current medications. However, it mentions that participants should be on heart failure guideline-directed medical therapy, so you may need to continue those medications.

What data supports the effectiveness of the treatment His Bundle vs Biventricular Pacing for Heart Failure?

Research shows that cardiac resynchronization therapy (CRT) using left bundle branch pacing (LBBP) and His-bundle pacing (HBP) can be effective alternatives to biventricular pacing (BVP) for heart failure patients, especially those with left bundle branch block (LBBB). Studies indicate that LBBP and HBP may provide better outcomes for some patients who do not respond well to traditional BVP-CRT. ^{1 2 3 4 5}

Is His Bundle or Biventricular Pacing safe for humans?

The research does not provide specific safety data for His Bundle or Biventricular Pacing, but these methods are commonly used for cardiac resynchronization therapy in heart failure patients, suggesting they are generally considered safe in clinical practice. ^{1 5 6 7 8}

How does His Bundle and Left Bundle Branch Pacing differ from other heart failure treatments?

His Bundle Pacing (HBP) and Left Bundle Branch Pacing (LBBP) are unique because they aim to restore the heart's natural electrical conduction system, potentially offering more natural heartbeats compared to traditional Biventricular Pacing (BiVP). This approach may benefit patients who do not respond to standard BiVP, as it can achieve better electrical synchrony in the heart. ^{1 4 5 7 9}

Research Team

Kenneth Ellenbogen, MD

Principal Investigator

Virginia Commonwealth University

Mihail Chelu, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for adults over 18 with heart failure and left ventricular dysfunction (LVEF≤50%), who are on standard heart failure meds, have a wide QRS (≥130 ms), or need/already have >40% right ventricular pacing. It's not for those with short life expectancy, certain preexisting conditions, recent heart attacks or procedures, reversible cardiomyopathies, severe valve disease, or women who are pregnant.

Inclusion Criteria

Your heart's pumping ability is less than 50% within the past 6 months.

I am 18 years old or older.

My heart failure treatment follows the latest guidelines.

Exclusion Criteria

I had a heart attack confirmed by tests in the last 3 months.

I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.

I have Chagas disease, cardiac sarcoidosis, or amyloidosis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either His/Left bundle branch pacing or biventricular pacing, with device implantation and monitoring

12 months

Regular visits for device monitoring and adjustment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of heart failure hospitalization and mortality

5.5 years

Annual visits for outcome assessment

Treatment Details

Interventions

• BiVP (Cardiac Pacing)
• His/LBBP (Cardiac Pacing)

Trial Overview The study compares His bundle or Left bundle branch pacing against standard biventricular pacing in improving quality of life and reducing hospitalizations and mortality in patients with systolic dysfunction and wide QRS complex. It also assesses the safety regarding device complications like lead dislodgement and infection.

Participant Groups

Group I: Biventricular Pacing (BiVP) Active Control 1 Intervention

Patients with LVEF≤35% at entry will receive a BiV defibrillator which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular ICD lead, and and an epicardial left ventricular lead implanted in a branch of the coronary sinus. Patients with LVEF 36-50% at entry will receive BiV pacemaker which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular pacing lead, and and an epicardial left ventricular lead implanted in a branch of the coronary sinus.

Group II: His/Left Bundle Branch Pacing (His/LBBP) Active Control 1 Intervention

Patients with LVEF≤35% at entry will receive a His/LBB defibrillator which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular ICD lead, and an endocardial His-bundle or left bundle branch pacing lead directly pacing the intrinsic conduction system. Patients with LVEF 36-50% at entry will receive His/LBB pacemaker which includes implantation of two leads, an endocardial right atrial lead, and an endocardial His-bundle or left bundle branch pacing lead directly pacing the intrinsic conduction system.

BiVP is already approved in Canada for the following indications:

Approved in Canada as Biventricular Pacing for:

• Heart failure with reduced left ventricular ejection fraction (LVEF)
• Wide QRS complex

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Cleveland Clinic Florida

Collaborator

Trials

16

Recruited

6,800+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

East Carolina University

Collaborator

Trials

111

Recruited

42,400+

Findings from Research

A meta-analysis of 10 studies involving 1063 heart failure patients showed that left bundle branch pacing (LBBP) significantly reduced heart failure hospitalization rates compared to biventricular pacing (BVP), with a risk ratio of 0.60.

LBBP-CRT also improved other important measures, including left ventricular ejection fraction (LVEF) and pacing thresholds, and resulted in a higher percentage of patients classified as responders and super-responders compared to BVP-CRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left bundle branch pacing versus biventricular pacing for cardiac resynchronization therapy: A systematic review and meta-analysis. Parlavecchio, A., Vetta, G., Caminiti, R., et al.[2023]

In a study of 100 patients with heart failure and left bundle branch block, left bundle branch pacing cardiac resynchronization therapy (LBBP-CRT) showed a higher success rate (98%) compared to optimized biventricular pacing (BVP-aCRT) at 91%, indicating LBBP-CRT is a feasible and effective option.

LBBP-CRT resulted in greater improvements in left ventricular ejection fraction and a higher rate of super-responses at both 6 months and 1 year compared to BVP-aCRT, suggesting it may provide better clinical outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac resynchronization therapy via left bundle branch pacing vs. optimized biventricular pacing with adaptive algorithm in heart failure with left bundle branch block: a prospective, multi-centre, observational study. Chen, X., Ye, Y., Wang, Z., et al.[2023]

Permanent His-bundle pacing (HBP) was successful in 90% of patients (95 out of 106), showing it as a feasible alternative for cardiac resynchronization therapy (CRT) in those who either failed biventricular pacing (BVP) or had indications for CRT.

After an average follow-up of 14 months, patients experienced significant improvements, including a reduction in QRS duration from 157 ms to 117 ms, an increase in left ventricular ejection fraction from 30% to 43%, and a better functional class, indicating that HBP effectively enhances heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Permanent His-bundle pacing as an alternative to biventricular pacing for cardiac resynchronization therapy: A multicenter experience. Sharma, PS., Dandamudi, G., Herweg, B., et al.[2018]

In two patients with end-stage heart failure, upgrading from conventional right ventricular apical and left ventricular pacing (BiVRVA+LV) to His-bundle pacing combined with left ventricular pacing (BiVHB+LV) led to significant improvements in heart failure status.

This suggests that BiVHB+LV pacing may be a more effective option for patients with advanced heart failure and conduction defects, as it addresses issues of dyssynchrony that conventional pacing may not fully correct.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upgrade of cardiac resynchronization therapy by utilizing additional His-bundle pacing in patients with inotrope-dependent end-stage heart failure: a case series. Baba, M., Yoshida, K., Hanaki, Y., et al.[2022]

His bundle pacing (HBP) can effectively shorten left ventricular activation times (LVAT) in 87.5% of patients with left bundle branch block (LBBB), with 33.3% achieving complete ventricular resynchronization similar to normal heart patterns.

Noninvasive electrocardiographic mapping can help identify which patients with LBBB are likely to benefit from HBP, suggesting that HBP may offer better resynchronization compared to biventricular pacing (BVP).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocardiographic predictors of successful resynchronization of left bundle branch block by His bundle pacing. Arnold, AD., Shun-Shin, MJ., Keene, D., et al.[2022]

In a study of 137 patients with severe heart failure, left bundle branch pacing (LBBP) and His bundle pacing (HBP) showed similar and significant improvements in left ventricular ejection fraction (LVEF) and symptoms compared to biventricular pacing (BVP), which had lower efficacy.

LBBP was associated with higher R-wave amplitude and lower pacing thresholds than HBP, suggesting it may be a more effective method for cardiac resynchronization therapy (CRT) and warrants further investigation in randomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Bundle Branch Pacing for Cardiac Resynchronization Therapy: Nonrandomized On-Treatment Comparison With His Bundle Pacing and Biventricular Pacing. Wu, S., Su, L., Vijayaraman, P., et al.[2021]

In a study of 21 patients with heart failure and left bundle branch block, left bundle branch pacing (LBBP) showed greater improvements in electrical and mechanical synchrony compared to biventricular pacing (BVP), including a significant reduction in QRS duration and area.

LBBP also resulted in a higher increase in hemodynamic performance, as measured by the maximum rate of left ventricular pressure rise (dP/dtmax), indicating it may be a more effective option for cardiac resynchronization therapy in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. Liang, Y., Wang, J., Gong, X., et al.[2022]

His-bundle pacing (HBP) is a feasible alternative to biventricular pacing (BiVP) for cardiac resynchronization therapy (CRT), showing equivalent clinical responses in patients with heart failure after 1 year of follow-up.

In a study of 29 patients, 72% showed electrical resynchronization with HBP, indicating that this method may be effective for a broader range of patients with left bundle branch block than previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

His-bundle pacing versus biventricular pacing in cardiac resynchronization therapy patients: A crossover design comparison. Lustgarten, DL., Crespo, EM., Arkhipova-Jenkins, I., et al.[2016]

References

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

Left bundle branch pacing versus biventricular pacing for cardiac resynchronization therapy: A systematic review and meta-analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cardiac resynchronization therapy via left bundle branch pacing vs. optimized biventricular pacing with adaptive algorithm in heart failure with left bundle branch block: a prospective, multi-centre, observational study. [2023]

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

Permanent His-bundle pacing as an alternative to biventricular pacing for cardiac resynchronization therapy: A multicenter experience. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Upgrade of cardiac resynchronization therapy by utilizing additional His-bundle pacing in patients with inotrope-dependent end-stage heart failure: a case series. [2022]

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

Electrocardiographic predictors of successful resynchronization of left bundle branch block by His bundle pacing. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Left Bundle Branch Pacing for Cardiac Resynchronization Therapy: Nonrandomized On-Treatment Comparison With His Bundle Pacing and Biventricular Pacing. [2021]

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

His-bundle and left bundle pacing with optimized atrioventricular delay achieve superior electrical synchrony over endocardial and epicardial pacing in left bundle branch block patients. [2021]

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

Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. [2022]

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

His-bundle pacing versus biventricular pacing in cardiac resynchronization therapy patients: A crossover design comparison. [2016]