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Heart surgery upgrade: zap away bad rhythms while implanting pump

NCT ID NCT05034432

Disease control Sponsor: University of Rochester 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Updated 2 times

Summary

This study tests whether destroying small areas of heart muscle that cause dangerous rhythms (ventricular tachycardia ablation) during LVAD implant surgery can reduce the number of these rhythms after surgery. About 100 adults with advanced heart failure who are getting an LVAD will be randomly assigned to either receive the ablation during surgery or standard care. The main goal is to see if the ablation lowers the total number of dangerous heart rhythm events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intra-operative ventricular tachycardia ablation (a procedure to destroy small areas of heart muscle that cause abnormal rhythms)
What this could lead to
If it works, this could reduce dangerous heart rhythms after LVAD surgery, potentially lowering hospitalizations and improving recovery.
What could go wrong
This is a phase 4 trial with only 100 participants, so results may not apply to everyone. The ablation itself carries risks like bleeding or damage to the heart.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

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

Started

May 2022

Expected to finish

Jun 2027

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: * Age \> 18 years * Presence of advanced cardiomyopathy (of all INTERMACS classification) and eligible for LVAD implant per the decision of the Heart Failure clinical team * Implanted cardioverter defibrillator (ICD) any time in past with remote monitoring or planned to undergo ICD (or ICM as an alternative, if an ICD cannot be implanted for a clinical reason) implant within the index hospitalization for LVAD implant * History of treated or monitored sustained (i.e., \>30 seconds in duration ) VT or VF episode within the past 5 years. Exclusion Criteria: * Past successful VTA ablation without recurrent VTA prior to LVAD implant (Patients who continue to experience VTA post ablation and pre LVAD implant qualify to be enrolled) * Participation in other clinical trials (observational registries are allowed with approval) * Unable or unwilling to provide informed consent

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac rhythm disease cardiomyopathy ventricular fibrillation ventricular tachycardia

As listed by the trial registrant

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

Arrythmia Cardiomyopathies

How to take part

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

  1. The places running it

    19 sites. 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

  • Ascension St. Vincent Indianapolis

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Banner University Medical Center

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10026, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medstar Washington Hospital Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UCLA Cardiac Arrthmia Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Univedrsity of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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