His-Bundle Corrective Pacing in Heart Failure

Description

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

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Study Overview

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Study Details

Study overview

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).

His-Bundle Corrective Pacing in Heart Failure

His-Bundle Corrective Pacing in Heart Failure

Condition
Right Bundle-Branch Block
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Paramus

Valley Health System, Paramus, New Jersey, United States, 07652

Burlington

University of Vermont, Burlington, Vermont, United States, 05401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester,

Valentina Kutyifa, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Rochester

Roderick Tung, MD, PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

2027-07-01