CONVERGE Post-Approval Study (PAS)

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 Agency's PMA approval of the CONVERGE pivotal trial.

Currently there are no FDA-approved treatment options available for patients diagnosed with drug refractory, long-standing persistent AF, which is known to increase the risk of stroke by five-fold.

The CONVERGE trial was conducted to address the treatment need in patients with advanced forms of AF, using a hybrid epicardial plus endocardial ablation approach. The Hybrid Convergent procedure and the EPi-Sense device have evolved over the past decade and now has a robust history of clinical use in approximately 10,000 patients.

The totality of evidence generated from the CONVERGE trial and published literature provides reasonable assurance of the safety and effectiveness of the Hybrid Convergent procedure for the treatment of longstanding-persistent AF, which AtriCure believes will facilitate evidence-based decision-making between physicians and patients in addressing this disease for which there are no treatment options.

A post-approval study synopsis is proposed herein to bolster the results of the CONVERGE pre-market pivotal study. Specifically, the aim of this study is to:

• Further confirm the effectiveness of the EPi-sense device in a larger sample size by narrowing confidence intervals.
• Demonstrate the proposed standard of care patient guidelines and mitigations for inflammatory pericardial effusions further reduce the observed safety event rates.
• Demonstrate that the CONVERGE pre-market pivotal study results are generalizable across operators with varying levels of experience.

Collect and report on long term outcomes of the Hybrid Convergent procedure.

Inclusion criteria

• 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 criteria

• 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