Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05265520

His-Bundle Corrective Pacing in Heart Failure

Led by University of Rochester · Updated on 2026-02-09

120

Participants Needed

14

Research Sites

291 weeks

Total Duration

On this page

Sponsors

U

University of Rochester

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

His-Bundle Corrective Pacing in Heart Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older (no upper age limit)
  • Receiving optimal medical therapy for heart failure as per current guidelines
  • Indication for CRT-D device implant based on guideline class IIa or IIb for RBBB patients, including:
    • NYHA class II heart failure symptoms, LVEF 64 30%, and QRS duration 65 150 ms (class IIb); OR
    • NYHA class III-IVa heart failure, LVEF 64 35%, and QRS duration 65 150 ms (class IIa); OR
    • NYHA class III-IVa heart failure, LVEF 64 35%, and QRS duration 120-149 ms (class IIb)
Not Eligible

You will not qualify if you...

  • No recent echocardiogram imaging available within 1 year prior to randomization
  • Presence of left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) on ECG
  • Unable or unwilling to follow the study protocol
  • Life expectancy less than 12 months at time of consent
  • Pregnancy or planning pregnancy during the study
  • Currently on heart transplant list or likely to undergo heart transplant

AI-Screening

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Trial Site Locations

Total: 14 locations

1

University of Arizona

Phoenix, Arizona, United States, 85006

Actively Recruiting

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

3

University of South Florida

Tampa, Florida, United States, 33606

Actively Recruiting

4

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

5

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

6

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

7

Valley Health System

Ridgewood, New Jersey, United States, 07450

Actively Recruiting

8

Weill Cornell Medical College

New York, New York, United States, 10021

Actively Recruiting

9

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

10

Mission Health

Asheville, North Carolina, United States, 28803

Actively Recruiting

11

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

12

Geisinger Wyoming Valley

Wilkes-Barre, Pennsylvania, United States, 18711

Actively Recruiting

13

University of Vermont

Burlington, Vermont, United States, 05401

Actively Recruiting

14

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

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Research Team

A

Ann Colasurdo

CONTACT

M

Mary Brown

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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His-Bundle Corrective Pacing in Heart Failure | DecenTrialz