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Cardiac Pacing

His Bundle vs Biventricular Pacing for Heart Failure

N/A

Recruiting

Led By Mihail G Chelu, MD, PhD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are optimized on HF guideline directed medical therapy according to current HF published guidelines

Be older than 18 years old

Must not have

Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment

Women who are pregnant, lactating, or plan to become pregnant during the course of the trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how different pacemakers affect quality of life, physical activity, heart failure hospitalizations, and mortality in those with heart failure.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include issues related to the pacemaker such as local infection at the implant site, lead dislodgement requiring re-intervention, bleeding or bruising around the area where the device was implanted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart failure treatment follows the latest guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My heart condition can improve and was not caused by reduced blood flow.

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I have Chagas disease, cardiac sarcoidosis, or amyloidosis.

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I have a severe heart valve problem.

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I am allergic to contrast dye and cannot or will not take pre-treatment for it.

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I can regularly visit the clinic for follow-ups.

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I am expected to get a heart pump or heart transplant within 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

A combined clinical endpoint of all-cause mortality and hospitalization for heart failure

Secondary study objectives

Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at 12 months

Cardiovascular hospitalization at 5.5 years

Change in NYHA Classification at 12 months

+5 more

Other study objectives

Appropriate ICD therapy for ventricular arrhythmias

Change in Left Ventricular Ejection Fraction (LVEF) at 12 months

Change in NT-proBNP at 12 months

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Biventricular Pacing (BiVP)Active Control1 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 Control1 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.

0 / 9Eligibility criteria met