STOP Persistent AF

Inclusion Criteria:

- Documentation of symptomatic persistent AF: Defined as having a continuous episode
lasting longer than 7 days but less than 6 months documented by consecutive ECG
recordings OR Defined as having a continuous episode lasting longer than 7 days but
less than 6 months documented by an ECG recording and one doctor note indicating
patient had symptoms consistent with AF

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

- Age 18 or older (or older than 18 if required by local law)

Exclusion Criteria:

- Left atrial diameter > 5.0 cm (anteroposterior)

- Prior left atrial ablation or surgical procedure (including left atrial appendage
closures)

- Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop
recorder, or any type of implantable cardiac defibrillator (with or without
biventricular pacing function) within 12 months

- Presence of any pulmonary vein stents

- Presence of any pre-existing pulmonary vein stenosis

- Pre-existing hemidiaphragmatic paralysis

- Presence of any cardiac valve prosthesis

- +3 and +4 mitral valve regurgitation or stenosis

- Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting
which occurred during the 3 month interval preceding the consent date

- Unstable angina

- NYHA Class III or IV congestive heart failure and/or documented left ventricular
ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac
testing (e.g. TTE)

- Primary pulmonary hypertension

- Rheumatic heart disease

- Thrombocytosis, thrombocytopenia

- Any condition contraindicating chronic anticoagulation

- Active systemic infection

- Hypertrophic cardiomyopathy

- Cryoglobulinemia

- Uncontrolled hyperthyroidism

- Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month
interval preceding the consent date

- Any woman known to be pregnant or breastfeeding, or any woman of child bearing
potential who is not on a reliable form of birth regulation method or abstinence

- Life expectancy less than one year

- Current or anticipated participation in any other clinical trial of a drug, device or
biologic during the duration of the study not pre-approved by Medtronic

- Known allergies or hypersensitivities to adhesives

- Known drug or alcohol dependency

- Unwilling or unable to comply fully with study procedures and follow-up