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Heart surgery plus ablation: a One-Two punch against stubborn AFib?

NCT ID NCT03546374

Disease control Sponsor: Medtronic Cardiac Surgery 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether using a special radiofrequency ablation device during open-heart surgery can safely stop persistent atrial fibrillation (AFib). About 160 people with long-lasting AFib who need heart surgery for other reasons will receive the ablation. The goal is to see if the procedure can restore normal heart rhythm without major complications.

What this could mean

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

Active substance
Irrigated radiofrequency ablation and cryoablation devices
What this could lead to
If successful, this could provide a safe and effective way to treat persistent atrial fibrillation during open-heart surgery, potentially reducing the need for long-term medication.
What could go wrong
This is a mid-stage study with only 160 participants, and the procedure carries risks like bleeding, stroke, or heart damage. Results may not apply to all patients.

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 160 people

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

Started

Nov 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * History of non-paroxysmal AF (persistent or longstanding persistent) * Concomitant indication for non-emergent open-heart surgery, eg, 1. Coronary artery bypass grafting 2. Valve repair or replacement * Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC) Exclusion Criteria: * Wolff-Parkinson-White syndrome * New York Heart Association (NYHA) Class = IV * Left Ventricular Ejection Fraction ≤ 30% * Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery * Previous AF ablation, atrioventricular (AV) -nodal ablation, or surgical Maze procedure * Contraindication for anticoagulation therapy * Left atrial diameter \> 6.0 cm * Preoperative need for an intra-aortic balloon pump or intravenous inotropes * Renal failure requiring dialysis or hepatic failure * Life expectancy of less than 1 year * Predicted risk of operative mortality \>10% as assessed by STS Risk Calculator * Pregnancy or desire to be pregnant within 12 months of the study treatment * Current diagnosis of active systemic infection * Active endocarditis * Documented MI 30 days prior to study enrollment * Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias

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Conditions

The condition(s) this trial relates to.

atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Longstanding persistent atrial fibrillation Persistent atrial fibrillation

How to take part

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

  1. The places running it

    7 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

  • Adventist Health St. Helena

    WITHDRAWN

    St. Helena, California, 94574, United States

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Hartford Healthcare

    COMPLETED

    Hartford, Connecticut, 06102, United States

  • Intermountain Medical Center

    COMPLETED

    Murray, Utah, 84107, United States

  • Lankenau Medical Center

    COMPLETED

    Wynnewood, Pennsylvania, 19096, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • ProMedica Toledo

    COMPLETED

    Toledo, Ohio, 43606, United States

  • Sentara Norfolk General Hospital

    COMPLETED

    Norfolk, Virginia, 23507, United States

  • St Vincent Heart Center of Indiana

    RECRUITING

    Indianapolis, Indiana, 46290, United States

  • St. Joseph Medical Center

    WITHDRAWN

    Tacoma, Washington, 98405, United States

  • Stanford Hospitals and Clinic

    COMPLETED

    Palo Alto, California, 94304, United States

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98122, United States

  • Virginia Mason Heart Institute

    RECRUITING

    Seattle, Washington, 98101, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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