nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF

The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered
Coagulation System with VisiTrax when used to treat persistent and longstanding persistent
Atrial Fibrillation(AF)during concomitant cardiac surgery.

Inclusion Criteria:

- Age > 18 years; < 80 years

- Left atrium =< 6.0 cm

- Documented persistent or longstanding persistent AF

- History of AF =< 10 years

- Scheduled for a concomitant cardiac procedure

- Coronary bypass surgery (CABG)

- Mitral valve repair/replacement

- Aortic valve replacement

- ASD repair

- Tricuspid valve repair/replacement

- Myxoma

- Any combination of the above procedures

- Provided written informed consent

Exclusion Criteria:

- Left atrial size > 6.0 cm (pre-op TTE - parasternal 4 chamber view)

- History of AF > 10 years

- Left ventricular ejection fraction < 30%

- Pregnant or planning to become pregnant during study

- Co-morbid medical conditions that limit one year life expectancy

- History of coagulopathy

- Patients who are contraindicated for anticoagulants(heparin, warfarin etc.)

- Previous cardiac surgery

- History of pericarditis

- Previous cerebrovascular accident (CVA)

- Patients who have active infection or sepsis

- Patients who have uncorrected reversible cause(s) of AF such as hyperthyroidism and
electrolyte imbalance

- Patients who are being treated for ventricular arrhythmias

- Patients who have had a previous catheter ablation for AF (does not include ablation
for Aflutter)

- 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).