CLOSE to CURE Study

Inclusion criteria

• Patients with symptomatic paroxysmal AF (history of self-terminating AF within 7 days or history of self-terminating AF with 1 or more cardioversions within 48 hours after onset), meeting following criteria at the out-patient clinic:

• patient has at least 3 AF episodes in the last 3 months prior to the visit
• AF episodes are symptomatic, and patient is drug-resistant (at least one class IC or III), or drug-intolerant (palpitations, fatigue, dyspnea, cardiomyopathy,…)
• no advanced structural heart disease
• patient has a CHA2DS2-VASc score of 0, 1, 2, 3 or 4
• Signed Patient Informed Consent Form.
• Age 18 years or older.
• Able and willing to comply with all follow-up testing and requirements.

Exclusion criteria

• Persistent atrial fibrillation (history of AF>7days or history of cardioversion > 48h of AF)
• Previous ablation for AF
• LA antero-posterior diameter > 50 mm (parasternal long axis view , PLAX)
• LVEF < 35% (ejection fraction)
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Coronary artery bypass grafting (CABG) procedure within the last three months
• Awaiting cardiac transplantation or other cardiac surgery
• Documented left atrial thrombus on imaging
• Diagnosed atrial myxoma
• Women who are pregnant or breastfeeding
• Acute illness or active systemic infection or sepsis
• Unstable angina
• Uncontrolled heart failure
• Myocardial infarction within the previous two months
• History of blood clotting or bleeding abnormalities
• Contraindication to anticoagulation therapy (ie, heparin or warfarin)
• Life expectancy less than 12 months
• Enrollment in any other study evaluating another device or drug
• Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction