CONVERGE Post-Approval Study (PAS)

Running, not enrolling · Not applicable

Conditions studied: Chronic Atrial Fibrillation

In brief

The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

Key facts

Study ID

NCT05393180

Run by

AtriCure, Inc.

People needed

53

Starts

2022-04-13

Expected to finish

2028-11-21

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years and < 80 years at time of enrollment consent;
• Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography [TTE] with parasternal 4 chamber view or equivalent imaging modality;
• Refractory or intolerant to at least one AAD (class I and/or III);
• 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);
• Life expectancy > 12 months; and
• Provides written informed consent.

You may not qualify if…

• Patients requiring concomitant surgery such as valvular repair or replacement, coronary artery bypass graft (CABG) surgery and atrial septal defect closure;
• Left ventricular ejection fraction < 35%;
• Pregnant or planning to become pregnant during study;
• Co-morbid medical conditions that limit one-year life expectancy;
• Previous cardiac surgery;
• History of pericarditis;
• Previous cerebrovascular accident (CVA), excluding fully resolved TIA;
• Patients who have active infection or sepsis
• Patients with esophageal ulcers strictures and varices;
• Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40);
• Patients who are contraindicated for anticoagulants such as heparin and coumadin;
• Patients who are being treated for ventricular arrhythmias;
• 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;
• 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;
• Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative);
• Patient has presence of thrombus in the left atrium determined by intraoperative TEE;
• Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins >50 % stenosis;
• Planned Left Atrial Appendage Management (LAAM) with an endocardial implantable device during the course of the study;
• 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
• Presence of Barretts esophagitis

Where it is running

• Sutter Bay Hospitals — San Francisco, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Baycare Health Systems — Clearwater, Florida, United States
• Orlando Health — Orlando, Florida, United States
• Emory Saint Joseph Hopsital — Atlanta, Georgia, United States
• Wellstar Health System — Marietta, Georgia, United States
• Norton Heart & Vascular Institute — Louisville, Kentucky, United States
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States
• Southcoast Hospitals Group — New Bedford, Massachusetts, United States
• AtlantiCare Medical Center — Atlantic City, New Jersey, United States
• Avera Heart Hospital of SD — Sioux Falls, South Dakota, United States
• University of Utah — Salt Lake City, Utah, United States
• St Thomas — London, United Kingdom

Full record on ClinicalTrials.gov

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