RECRUITING

His-Bundle Corrective Pacing in Heart Failure

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Conditions

Right Bundle-Branch BlockHeart FailureHis-bundle PacingCardiac Resynchronization Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

His-Bundle Corrective Pacing in Heart Failure

Quick Facts

Study Start:2022-12-02
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05265520

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.

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

Contacts and Locations

Study Contact

Ann Colasurdo
CONTACT
585-275-1054
ann.colasurdo@heart.rochester.edu
Mary Brown
CONTACT
585-273-5283
mary.brown@heart.rochester.edu

Principal Investigator

Valentina Kutyifa, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Rochester
Roderick Tung, MD
PRINCIPAL_INVESTIGATOR
University of Arizona

Study Locations (Sites)

University of Chicago
Chicago, Illinois, 60637
United States
Valley Health System
Paramus, New Jersey, 07652
United States
University of Vermont
Burlington, Vermont, 05401
United States

Collaborators and Investigators

Sponsor: University of Rochester

  • Valentina Kutyifa, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Rochester
  • Roderick Tung, MD, PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-02
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2022-12-02
Study Completion Date2027-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Right Bundle-Branch Block
  • Heart Failure
  • His-bundle Pacing
  • Cardiac Resynchronization Therapy