STOP Persistent AF
STOP Persistent AF
To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac
 CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent
 atrial fibrillation (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, percutaneous coronary intervention (PCI) /
 percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting
 which occurred during the 3 month interval preceding the consent date

 -  Unstable angina

 -  New York Heart Association (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. Transthoracic echocardiogram (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 transient ischemic attacks (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