Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL
SMARTTOUCH® SF catheter in the treatment of drug refractory symptomatic persistent atrial
fibrillation (PsAF) following standard electrophysiology mapping and RF ablation procedures.

Inclusion Criteria:

Candidates for this study must meet ALL of the following criteria:

1. Documented symptomatic persistent AF, which is defined as continuous AF sustains
beyond 7 days and less than 1 year and is documented by the following:.

1. Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND

2. Two electrocardiograms (from any forms of rhythm monitoring) showing continuous
AF, with electrocardiogram taken at least 7 days apart OR

3. 24-hour Holter within 90 days of the ablation procedure showing continuous AF

2. Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by
recurrent symptomatic AF, or intolerable to the AAD.

3. Age 18 years or older.

4. Signed Patient Informed Consent Form (ICF).

5. Able and willing to comply with all pre-, post-, and follow-up testing and
requirements.

Exclusion Criteria:

Candidates for this study will be EXCLUDED from the study if ANY of the following
conditions apply:

1. Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)

2. Previous surgical or catheter ablation for atrial fibrillation

3. Any cardiac surgery within the past 2 months (60 days) (includes PCI)

4. CABG surgery within the past 6 months (180 days)

5. Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and
valve repair or replacement and presence of a prosthetic valve)

6. Any carotid stenting or endarterectomy

7. Documented LA thrombus on imaging

8. LA size > 50 mm (parasternal long axis view)

9. LVEF < 40%

10. Contraindication to anticoagulation (heparin or warfarin)

11. History of blood clotting or bleeding abnormalities

12. MI within the past 2 months (60 days)

13. Documented thromboembolic event (including TIA) within the past 12 months (365 days)

14. Rheumatic Heart Disease

15. Uncontrolled heart failure or NYHA function class III or IV

16. Severe mitral regurgitation (Regurgitant volume ≥ 60 mL/beat, Regurgitant fraction ≥
50%, and/or Effective regurgitant orifice area ≥ 0.40cm2)

17. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
(365 days)

18. Unstable angina

19. Acute illness or active systemic infection or sepsis

20. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac
cause.

21. Diagnosed atrial myxoma.

22. Presence of implanted ICD/CRT-D.

23. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or
chronic obstructive pulmonary disease) or any other disease or malfunction of the
lungs or respiratory system that produces chronic symptoms.

24. Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not
including OTC medication)

25. Significant congenital anomaly or medical problem that in the opinion of the
investigator would preclude enrollment in this study.

26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)

27. Enrollment in an investigational study evaluating another device, biologic, or drug.

28. Presence of intramural thrombus, tumor or other abnormality that precludes vascular
access, or manipulation of the catheter.

29. Presence of any other condition that precludes appropriate vascular access.

30. Life expectancy less than 12 months