NCT05265520NARecruiting

His-Bundle Corrective Pacing in Heart Failure

University of Rochester

Start Date

12/2/2022

Completion Date

7/1/2028

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).

Detailed Description

In this prospective, randomized, multi-center clinical trial, 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 Right Bundle Branch Block (RBBB) Electrocardiogram (ECG) Pattern by assessing the improvement in left ventricular ejection fraction (LVEF) in the His-CRT vs. BIV-CRT arm at 6 months, and by evaluating changes in ECG biomarkers, NT-pro-brain natriuretic peptide (NT-proBNP) levels, and echocardiography biomarkers (left ventricular volumes, strain contractility, and dyssynchrony), as well as temporal changes in functional status and quality of life in the His-CRT vs. BIV-CRT arm at 6, 12, and 24 months.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age 18 years or older (no upper age limit) * Optimal medical therapy for heart failure by current guidelines * Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following: * New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR * NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR * NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb) Exclusion Criteria: * Unable to obtain most recent imaging data from echocardiogram within 1 year prior to date of randomization * Left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) ECG morphology * Unable or unwilling to follow study protocol * Less than 12 months life expectancy at consent * Pregnancy or planned pregnancy during duration of the study * On heart transplant list or likely to undergo heart transplant

Interventions

PROCEDURE

His-CRT implantation

PROCEDURE

BIV-CRT implantation

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Conditions

Right Bundle-Branch BlockHeart FailureHis-bundle PacingCardiac Resynchronization Therapy

Locations

University of Arizona

Phoenix, Arizona 85006

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

University of South Florida

Tampa, Florida 33606

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

University of Chicago

Chicago, Illinois 60637

United States

Valley Health System

Ridgewood, New Jersey 07450

United States

Weill Cornell Medical College

New York, New York 10021

United States

Mount Sinai Hospital

New York, New York 10029

United States

Mission Health

Asheville, North Carolina 28803

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania 18711

United States

University of Vermont

Burlington, Vermont 05401

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States