New hybrid heart procedure aims to tame stubborn AFib
NCT ID NCT05393180
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
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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
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53 people
The number who actually took part.
- Started
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Apr 2022
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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AtlantiCare Medical Center
Atlantic City, New Jersey, 08401, United States
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Avera Heart Hospital of SD
Sioux Falls, South Dakota, 57108, United States
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Baycare Health Systems
Clearwater, Florida, 33759, United States
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Emory Saint Joseph Hopsital
Atlanta, Georgia, 30322, United States
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Hartford Hospital
Hartford, Connecticut, 06102, United States
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MedStar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
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Norton Heart & Vascular Institute
Louisville, Kentucky, 40205, United States
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Orlando Health
Orlando, Florida, 32806, United States
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Southcoast Hospitals Group
New Bedford, Massachusetts, 02740, United States
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St Thomas
London, Se1 7EH, United Kingdom
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Sutter Bay Hospitals
San Francisco, California, 94107, United States
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University of Utah
Salt Lake City, Utah, 84112, United States
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Wellstar Health System
Marietta, Georgia, 30062, United States
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