CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)

Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF

This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).

The objective of this randomized pivotal study is to evaluate the safety and efficacy of the AtriCure EPi-Sense®-AF Guided Coagulation System with VisiTrax® for the treatment of symptomatic persistent Atrial Fibrillation (AF) patients, refractory or intolerant to at least one Class I or Class III anti-arrhythmic drug (AAD). 153 subjects from up to 27 US and 3 OUS sites. Randomized 2:1.

The primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-month post procedure follow-up visit.

The primary safety endpoint is the incidence of major adverse events (MAEs) listed in the protocol for subjects undergoing the convergent procedure for the procedural to 30-day post procedure time period.

Inclusion Criteria:

• Age > 18 years; < 80 years
• Left atrium < 6.0 cm
• Refractory or intolerant to one AAD (class I and/or III)
• Documentation of persistent AF
• Provided written informed consent

Exclusion Criteria:

• Patients requiring concomitant surgery
• Left ventricular ejection fraction < 40%
• 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 transient Ischemic attack (TIA)
• Patients who have active infection or sepsis
• Patients with esophageal ulcers strictures and varices
• Patients with renal dysfunction who are not on dialysis
• Patients who are contraindicated for anticoagulants
• Patients who are being treated for ventricular arrhythmias
• Patients who have had a previous left atrial catheter ablation for AF
• Patients with existing Implantable Cardioverter-Defibrillator (ICDs)
• 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