ArcticLine Feasibility Study

Inclusion Criteria:

- Documentation of symptomatic persistent AF:

- Defined as having a continuous episode that is sustained beyond 7 days documented
via consecutive ECG recordings, or

- Defined as having a continuous episode that is sustained beyond 7 days documented
by an ECG recording and one doctor note indicating the patient had symptoms
consistent with AF

- Age 18 through 80 years old

- Failure or intolerance of at least one Class I or III antiarrhythmic drug

- Subject is able and willing to consent to participate in the study and will commit to
completion of all follow-up requirements

Exclusion Criteria:

- Longstanding persistent AF, defined as continuous AF greater than 12 month duration

- Left atrial diameter greater than 5.0 cm

- Active systemic infection

- History of thromboembolic event within the past 6 months or evidence of intracardiac
thrombus at the time of the procedure

- Prior left atrial ablation attempt, with exception of:

- Any pulmonary vein isolation attempt to treat AF, or

- Successful ablation to treat Wolff-Parkinson White syndrome

- History of left atrial tachycardia

- History of cardiac ablation within 90 days of planned clinical study procedure

- Planned concomitant ventricular ablation

- Cryoglobulinemia

- Structural heart disease of clinical significance including:

- NYHA Class IV Heart Failure

- Diagnosed with NYHA Class III Heart Failure for more than six months at time of
the study ablation procedure

- LVEF less than 35%

- Any cardiac surgery (e.g. CABG) within 3 months of the ablation procedure

- Any mechanical heart valve, prior aortic or tricuspid valve replacement (e.g.
valvotomy, valve replacement), or tricuspid valve repair

- Severe mitral valve regurgitation or stenosis

- Significant congenital anomaly or anatomy unable to accommodate device

- Prior surgical maze procedure

- Unstable angina

- Myocardial infarction within 3 months of the ablation procedure

- Presence of primum or secundum atrial septal defect

- Anomalous pulmonary venous return

- Prior surgery for congenital heart disease, including atrial septal defect repair

- Hypertrophic cardiomyopathy with LV septal wall thickness >1.5 cm

- Uncontrolled hyperthyroidism

- Thrombocytosis, thrombocytopenia (including history of heparin-induced
thrombocytopenia)

- Severe comorbidity or poor general physical/mental health that, in the opinion of the
investigator, will not allow the subject to be a good study candidate

- History of blood clotting or bleeding abnormalities

- Contraindication to all anticoagulation (e.g. novel oral anticoagulants, heparin or
warfarin)

- Pregnant, nursing or planning to become pregnant during study duration

- Enrollment in another clinical trial without prior approval from Medtronic

- Presence or use of left atrial appendage closure device

- Presence of or planned implantation of a pacemaker, implantable cardiac defibrillator,
implantable loop recorder or cardiac resynchronization device with permanent lead
placement

- Pre-existing hemidiaphragmatic paralysis

- Life expectancy less than one year

- Known drug or alcohol dependency

- Existing pulmonary vein stent(s)