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New pacing technique could help heart failure patients live longer

NCT ID NCT05650658

Disease control Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a newer heart pacing method (His or left bundle branch pacing) against the standard method (biventricular pacing) in over 2,000 adults with heart failure and a weak heart pump. The goal is to see which approach better improves quality of life, reduces hospital stays, and lowers the risk of death. Participants will continue their usual heart failure medications alongside the pacing device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,136 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women 18 years of age or older. * A LVEF ≤ 50% within 6 months prior to enrollment. * Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR anticipated right ventricular pacing \>40% OR device in place with right ventricular pacing \> 40%. * Are optimized on HF guideline directed medical therapy according to current HF published guidelines OR patient's physician will make an effort to start all guideline-directed medical therapy and titrate doses up as permitted by the participant clinical status and co-morbidities prior to implantation procedure. Exclusion Criteria: * Women who are pregnant, lactating, or plan to become pregnant during the course of the trial. * Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months. * Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment. * Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment. * Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis). * Participants with Chagas disease, cardiac sarcoidosis or amyloidosis. * Expected to receive left ventricular assist device or heart transplantation within 6 months. * Participants with primary severe valvular disease (e.g., aortic stenosis). * Have a life expectancy of less than 12 months. * Participants with irreversible brain damage from preexisting cerebral disease. * Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine. * Participants participating in any other interventional cardiovascular clinical trial. * Participants who would be unable to comply with the study's follow-up visit schedule; or * Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device.

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Conditions

The condition(s) this trial relates to.

atrioventricular block bundle branch block, familial isolated complete right heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Av block Heart failure Heart failure with reduced ejection fraction Intraventricular conduction delay LBBB Pacing induced cardiomyopathy RBBB

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    71 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny-Singer Research Institute

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Baptist Health Louisville

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • CIS Clinical Research Corporation

    ENROLLING_BY_INVITATION

    Naperville, Illinois, 60540, United States

  • CIUSSS de l'Estrie - CHUS

    NOT_YET_RECRUITING

    Saint-Jean-sur-Richelieu, Quebec, Canada

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    RECRUITING

    Palm Beach Gardens, Florida, 33418, United States

  • Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC

    NOT_YET_RECRUITING

    South Pasadena, Florida, 33707, United States

  • Geisinger Commonwealth School of Medicine

    RECRUITING

    Scranton, Pennsylvania, 18510, United States

  • HMH Hospitals Corporation

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hamilton Health Sciences (HHS)

    RECRUITING

    Hamilton, Ontario, Canada

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • Heart Rhythm Solutions

    RECRUITING

    Davie, Florida, 33328, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Inova Heart and Vascular Institute

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Lehigh Valley Hospital Inc.

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Lovelace Medical Center

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • MH Mission Hospital LLLP- Asheville Cardiology Associates

    RECRUITING

    Asheville, North Carolina, 28803, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mazankowski Alberta Heart Institute/University of Alberta

    NOT_YET_RECRUITING

    Edmonton, Alberta, Canada

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ

    RECRUITING

    Gilbert, Arizona, 85297, United States

  • Montreal Heart Institute

    RECRUITING

    Montreal, Quebec, Canada

  • Mount Sinai Medical Center of Florida, Inc.

    NOT_YET_RECRUITING

    Miami Beach, Florida, 33140, United States

  • Newark Beth Israel Medical Center

    RECRUITING

    Newark, New Jersey, 07112, United States

  • Newmarket Electrophysiology Research Group Inc. (NERG)

    RECRUITING

    Newmarket, Ontario, Canada

  • Northwestern University

    RECRUITING

    Evanston, Illinois, 60208, United States

  • Nova Scotia Health Authority

    RECRUITING

    Halifax, Nova Scotia, Canada

  • Novant Health

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Penn Medicine Lancaster General

    RECRUITING

    Lancaster, Pennsylvania, 17603, United States

  • Prisma Health-Upstate

    NOT_YET_RECRUITING

    Greenville, South Carolina, 29605, United States

  • Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital

    RECRUITING

    Montreal, Canada

  • Rush University

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Sentara Healthcare

    RECRUITING

    Newport News, Virginia, 23606, United States

  • South Denver Cardiology Associates

    RECRUITING

    Littleton, Colorado, 80124, United States

  • St. Luke's University Health Network

    RECRUITING

    Allentown, Pennsylvania, 18015, United States

  • St. Mark's Hospital

    RECRUITING

    Salt Lake City, Utah, 84124, United States

  • Sunnybrook Research Institute

    RECRUITING

    Toronto, Ontario, Canada

  • Texas Health Research & Education Institute

    NOT_YET_RECRUITING

    Arlington, Texas, 76011, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The MetroHealth System

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • The Valley Hospital, Inc.

    RECRUITING

    Ridgewood, New Jersey, 07450, United States

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Trustees of Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • University of Arizona College of Medicine- Phoenix

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Arkansas for Medical Sciences (UAMS)

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of British Columbia

    RECRUITING

    Vancouver, British Columbia, Canada

  • University of Calgary

    RECRUITING

    Calgary, Canada

  • University of California San Diego

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado (Anschutz Medical Campus)

    RECRUITING

    Denver, Colorado, 80217, United States

  • University of Florida Jacksonville

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32211, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, Canada

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburg

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33613, United States

  • University of Vermont

    RECRUITING

    Burlington, Vermont, 05402, United States

  • University of Virginia Health System

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Université Laval

    RECRUITING

    Québec, Canada

  • Victoria Cardiac Arrhythmia Trials (VCAT) Inc.

    RECRUITING

    Victoria, British Columbia, Canada

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23284, United States

  • Virtua Health

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital

    RECRUITING

    Kitchener, Canada

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06511, United States

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