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New hybrid heart procedure aims to tame stubborn AFib

NCT ID NCT05393180

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at a procedure called hybrid convergent ablation for people with a long-lasting type of irregular heartbeat (atrial fibrillation) that hasn't improved with medication. The procedure uses heat energy to destroy heart tissue causing the problem, combining a small chest incision with a catheter through a vein. The goal is to see if it can safely restore a normal heart rhythm without needing more drugs or additional procedures.

Why investors are watching

AtriCure is a small company, so this trial's results carry outsized weight. The study tracks 53 patients with long-standing persistent atrial fibrillation who receive the EPi-Sense ablation system after drugs failed. A clear outcome could validate the device's use in a hard-to-treat group and shape the company's commercial story.

If it works: A positive result could strengthen the case for EPi-Sense as a treatment option for patients who do not respond to medication. That could support broader adoption and give the company a firmer footing in the atrial fibrillation market.

If it fails: The trial could fail to show meaningful benefit, or the company could face delays in reporting results. Trials often fail, and for a small company, a setback here could weigh on confidence in the product's future.

AI-written from the trial record. Speculative, and not investment advice.

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

53 people

The number who actually took part.

Started

Apr 2022

Expected to finish

Nov 2028

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 to 80 years

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: 1. Age ≥ 18 years and \< 80 years at time of enrollment consent; 2. Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography \[TTE\] with parasternal 4 chamber view or equivalent imaging modality; 3. Refractory or intolerant to at least one AAD (class I and/or III); 4. Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue) longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECAS Guidelines (\> 12 months of continuous AF); 5. Life expectancy \> 12 months; and 6. Provides written informed consent. Exclusion Criteria: 1. Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure; 2. Left ventricular ejection fraction \< 35%; 3. Pregnant or planning to become pregnant during study; 4. Co-morbid medical conditions that limit one-year life expectancy; 5. Previous cardiac surgery; 6. History of pericarditis; 7. Previous cerebrovascular accident (CVA), excluding fully resolved TIA; 8. Patients who have active infection or sepsis 9. Patients with esophageal ulcers strictures and varices; 10. Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40); 11. Patients who are contraindicated for anticoagulants such as heparin and coumadin; 12. Patients who are being treated for ventricular arrhythmias; 13. Patients who have had more than 2 prior left atrial catheter ablations for AF. NOTE: Note: Prior ablations should be limited to failed Pulmonary Vein Isolation (PVI) and no other left atrial lesions; 14. Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment; 15. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative); 16. Patient has presence of thrombus in the left atrium determined by intraoperative TEE; 17. Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins \>50 % stenosis; 18. Planned Left Atrial Appendage Management (LAAM) with an endocardial implantable device during the course of the study; 19. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results 20. Presence of Barretts esophagitis

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • AtlantiCare Medical Center

    Atlantic City, New Jersey, 08401, United States

  • Avera Heart Hospital of SD

    Sioux Falls, South Dakota, 57108, United States

  • Baycare Health Systems

    Clearwater, Florida, 33759, United States

  • Emory Saint Joseph Hopsital

    Atlanta, Georgia, 30322, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • Norton Heart & Vascular Institute

    Louisville, Kentucky, 40205, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • Southcoast Hospitals Group

    New Bedford, Massachusetts, 02740, United States

  • St Thomas

    London, Se1 7EH, United Kingdom

  • Sutter Bay Hospitals

    San Francisco, California, 94107, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • Wellstar Health System

    Marietta, Georgia, 30062, United States

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