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Cardiac Pacing

His-Bundle vs Biventricular Pacing for Heart Failure (HIS-CRT Trial)

N/A

Recruiting

Led By Valentina Kutyifa, MD, PhD

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

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

Must have

NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa)

Optimal medical therapy for heart failure by current guidelines

Must not have

Unable or unwilling to follow study protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trialwill compare two treatments for heart failure with RBBB to see which one works best.

Who is the study for?

This trial is for heart failure patients with right bundle branch block who meet specific criteria: they have certain levels of heart function and symptoms, are at least 18 years old, and follow optimal medical therapy. It's not for those with left bundle branch block, other ECG issues, or a life expectancy under one year.

What is being tested?

The study compares two types of pacemaker implantations in heart failure patients: His-bundle pacing (His-CRT) versus traditional cardiac resynchronization therapy (BIV-CRT). The goal is to see which method works better for correcting the heartbeat.

What are the potential side effects?

While the description doesn't list side effects explicitly, typical risks may include infection at the implant site, bleeding or bruising, lead displacement requiring repositioning, and rarely device malfunction.

Eligibility Criteria

Inclusion Criteria

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

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My heart function is severely reduced, and I have a specific heart rhythm pattern.

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I am receiving the best current treatment for heart failure.

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My heart function is severely reduced, with specific heart rhythm characteristics.

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My heart's pumping ability is weak, and I have moderate heart failure symptoms.

Exclusion Criteria

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

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I am willing and able to follow the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Left Ventricular Ejection Fraction at 6 months with His-CRT vs. BIV-CRT, in heart failure patients with Right bundle branch block (RBBB)

Secondary study objectives

Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers

Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in NT-proBNP

Assess the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in echocardiographic left ventricular end-diastolic volume (LVEDV)

+1 more

Other study objectives

Ascertain the mechanism of benefit on ventricular depolarization (QRS duration) over time, at 6 months, 12 months, and 24 months.

Heart failure (HF) or death events

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: BIV-CRT implantationActive Control1 Intervention

BIV-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.

Group II: His-CRT implantationActive Control1 Intervention

His-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an endocardial His-bundle pacing leads directly pacing the intrinsic conduction system.

0 / 5Eligibility criteria met