Continued Access Protocol (CAP-AF)

This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.

1. To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects free from one or more primary safety outcome measures—Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events (MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
2. To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
3. To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial.

Inclusion Criteria:

Subjects must fulfill ALL of the following criteria:

1. Documented PAF:

   • diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), AND
   • 2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing
2. ³ 18 and £ 75 years of age
3. Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.

Exclusion Criteria:

ANY of the following is regarded as a criterion for excluding a subject from the study:

1. Any previous left atrial (LA) ablation (except permissible retreatment subjects)
2. Any previous LA surgery
3. Current intracardiac thrombus (can be treated after thrombus is resolved)
4. Presence of any pulmonary vein stents
5. Presence of any pre-existing pulmonary vein stenosis
6. Pre-existing hemidiaphragmatic paralysis
7. Anteroposterior LA diameter > 5.5 cm by TTE
8. Presence of any cardiac valve prosthesis
9. Clinically significant mitral valve regurgitation or stenosis
10. Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
11. Unstable angina
12. Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
13. Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
14. NYHA class III or IV congestive heart failure
15. Left ventricular ejection fraction (LVEF) < 40%
16. 2º (Type II) or 3º atrioventricular block
17. Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
18. Brugada syndrome
19. Long QT syndrome
20. Arrhythmogenic right ventricular dysplasia
21. Sarcoidosis
22. Hypertrophic cardiomyopathy
23. Known cryoglobulinemia
24. Uncontrolled hyperthyroidism
25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
26. Any woman known to be pregnant

27. Any woman without freedom from pregnancy as demonstrated by one or more of the following conditions:

    • negative β-HCG test within 7 days prior to Start Date
    • history of surgical sterilization
    • postmenopausal and free of menses for at least 12 months.
28. Life expectancy less than one (1) year
29. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study
30. Unwilling or unable to comply fully with study procedures and follow-up