Status:
ACTIVE_NOT_RECRUITING
CONVERGE Post-Approval Study (PAS)
Lead Sponsor:
AtriCure, Inc.
Conditions:
Chronic Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
In accordance with FDA's Guidance on Balancing Premarket and Post Market Data Collection for Devices Subject to Premarket Approval AtriCure proposes to conduct a post-approval study following the Agen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2029
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05393180
Start Date
April 13 2022
End Date
January 1 2029
Last Update
November 24 2025
Active Locations (13)
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1
Sutter Bay Hospitals
San Francisco, California, United States, 94107
2
Hartford Hospital
Hartford, Connecticut, United States, 06102
3
Baycare Health Systems
Clearwater, Florida, United States, 33759
4
Orlando Health
Orlando, Florida, United States, 32806