Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

Clinical Evaluation of Therapy™ Cool Flex Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

The purpose of this study is to observe the performance of Therapy™ Cool Flex™ catheter by documenting the procedural parameters, major complications and recurrence of AF after ablation using Cool Flex ablation catheter for the treatment of paroxysmal atrial fibrillation.

This study is an observational clinical study which is not based on any specific endpoints.

Inclusion Criteria:

• A signed written Informed Consent form
• 18 years of age or older
• Agrees to comply with follow-up visits and evaluation
• Candidate for catheter ablation for the treatment of paroxysmal atrial fibrillation as per the hospital standard of care.

Exclusion Criteria:

• Persistent or Long standing AF
• CABG procedure within the last 180 days (six months).
• Documented left atrial thrombus on imaging [e.g. Transesophageal echocardiogram (TEE)].
• History of blood clotting or bleeding abnormalities.
• Contraindication to anticoagulation (i.e. heparin or warfarin).
• Enrollment in another investigational study evaluating device or drug that might impact the results of this study.
• Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
• Acute illness or active systemic infection or sepsis.
• Life expectancy less than 12 months.
• Uncontrolled heart failure or NYHA class IV heart failure.
• Myocardial Infarction within 8 weeks of enrollment or unstable angina