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Keep this study
Lead
AtriCure, Inc.
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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
Clareo Health | CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)
