Recruiting

His-Bundle Pacing

Sponsor:

University of Rochester

Code:

NCT05265520

Conditions

Right Bundle-Branch Block

Heart Failure

His-bundle Pacing

Cardiac Resynchronization Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

His-CRT implantation

BIV-CRT implantation

Study Details

Brief 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).

Conditions

Right Bundle-Branch Block

Heart Failure

His-bundle Pacing

Cardiac Resynchronization Therapy

Study ID

NCT05265520

Start date

Dec 2, 2022

Status verified date

Feb, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: His-CRT implantation

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.

active comparator: BIV-CRT implantation

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.

Interventions

His-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.

BIV-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.

Primary outcome measure

  • 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) [ Time Frame: 6 month ]

Central Contacts and Locations

Central contacts

Ann Colasurdo

585-275-1054ann.colasurdo@heart.rochester.edu

Mary Brown

585-273-5283mary.brown@heart.rochester.edu

Locations

University of Arizona

Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator:

Roderick Tung

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Eric Braunstein

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Principal Investigator:

Bengt Herweg

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Nishant Verma

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Timothy Larsen

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator:

Gaurav Upadhyay

Valley Health System

Recruiting

Ridgewood, New Jersey, United States, 07450

Principal Investigator:

Suneet Mittal

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Principal Investigator:

Jim Cheung

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Jacob Koruth

Mission Health

Recruiting

Asheville, North Carolina, United States, 28803

Principal Investigator:

Michael Manogue

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Robert Schaller

Geisinger Wyoming Valley

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Principal Investigator:

Pugazhendhi Vijayaraman

University of Vermont

Recruiting

Burlington, Vermont, United States, 05401

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Principal Investigator:

Kenneth Ellenbogen

More Information

Sponsor

University of Rochester

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-02-09.