RecruitingNot ApplicableNCT05265520

His-Bundle Corrective Pacing in Heart Failure


Sponsor

University of Rochester

Enrollment

120 participants

Start Date

Dec 2, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a pacemaker technique called His-bundle pacing — which delivers electrical signals through the heart's natural conduction pathway — works better than standard cardiac resynchronization therapy (CRT) in patients with heart failure and a specific type of electrical delay in the heart (right bundle branch block, or RBBB). **You may be eligible if...** - You are 18 years or older with heart failure - You are already on optimal medical therapy for heart failure - You have been recommended for a CRT-D (a combined defibrillator and resynchronization device) based on current guidelines - You have right bundle branch block (RBBB) on your ECG and your heart's pumping function (LVEF) is significantly reduced - You have moderate to severe heart failure symptoms (NYHA Class II–IV) **You may NOT be eligible if...** - You have left bundle branch block (LBBB) or a different type of conduction delay - Your life expectancy is less than 12 months - You are unable or unwilling to follow the study protocol - You don't have a recent echocardiogram within the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHis-CRT implantation

The pathophysiological process is utilized in His-Bundle corrective pacing, resulting in a faster and more homogeneous activation of the heart pacing directly via the intrinsic conduction system of the heart accompanied by a right atrial endocardial lead and a right ventricular endocardial lead.

PROCEDUREBIV-CRT implantation

Biventricular cardiac resynchronization therapy has been shown to improve outcomes by delivering synchronized electrical stimuli to the right and left ventricles utilizing an an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.


Locations(14)

University of Arizona

Phoenix, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of South Florida

Tampa, Florida, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Valley Health System

Ridgewood, New Jersey, United States

Weill Cornell Medical College

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Mission Health

Asheville, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, United States

University of Vermont

Burlington, Vermont, United States

Virginia Commonwealth University

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05265520


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