Evaluating outcomes of a new treatment for chronic atrial fibrillation

Hybrid Convergent of Epicardial and Endocardial RF Ablation for the Treatment of Symptomatic Longstanding Persistent AF

This study is testing a new treatment for people with long-standing atrial fibrillation to see if it can help them feel better and is safe to use.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 325 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: AtriCure, Inc. (Industry-sponsored)
• Locations: 14 sites (Newport Beach, California and 13 other locations)
• Trial ID: NCT05393180 on ClinicalTrials.gov

What this trial studies

The CONVERGE Post-Approval Study aims to assess the clinical outcomes of patients with symptomatic long-standing persistent atrial fibrillation who are treated with the EPi-Sense Guided Coagulation System. This study follows the FDA's approval of the Hybrid Convergent procedure, which combines epicardial and endocardial ablation techniques. By analyzing a larger cohort of patients, the study seeks to confirm the effectiveness and safety of this treatment approach, which currently has no FDA-approved alternatives for drug-refractory cases. The findings will help inform clinical decision-making for patients suffering from this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with symptomatic long-standing persistent atrial fibrillation who are refractory or intolerant to at least one antiarrhythmic drug.

Not a fit: Patients requiring additional cardiac surgeries or with significant comorbidities that limit their life expectancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with chronic atrial fibrillation who have not responded to existing medications.

How similar studies have performed: Previous studies have shown promising results with similar hybrid ablation techniques, indicating a potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Newport Beach, California and 13 other locations

• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (Withdrawn)
• Sutter Bay Hospitals — San Francisco, California, United States (Recruiting)
• Hartford Hospital — Hartford, Connecticut, United States (Recruiting)
• Baycare Health Systems — Clearwater, Florida, United States (Recruiting)
• Emory Saint Joseph Hopsital — Atlanta, Georgia, United States (Recruiting)
• Ascension St. Vincent — Indianapolis, Indiana, United States (Recruiting)
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States (Recruiting)
• Southcoast Hospitals Group — New Bedford, Massachusetts, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Withdrawn)
• University of Utah — Salt Lake City, Utah, United States (Recruiting)
• Bon Secours — Midlothian, Virginia, United States (Recruiting)
• Virginia Mason Medical Center — Seattle, Washington, United States (Recruiting)
• St Thomas — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Denise Breiner

Conditions Chronic Atrial Fibrillation