Clinical Trials

Inclusion Criteria

• Subjects with paroxysmal atrial fibrillation who have had two or more spontaneously terminating episodes of atrial fibrillation
  • longer than 30 seconds and shorter than 7 days, in the nine months prior to enrollment.
  • At least one episode must be documented with EKG, TTM, Holter monitor, or telemetry.
• Failure of at least one Class I - IV anti-arrhythmic drug (AAD) for PAF as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AADs
• Signed informed consent.
• Age 18 years or older
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous ablation for atrial fibrillation.
• Atrial fibrillation episodes that last less than 7 days and are terminated by cardioversion.
• Previous valvular cardiac surgery procedure.
• Cardiac artery bypass graft procedure within the previous 180 days.
• Previous septal defect repair.
• Expecting cardiac transplantation or other cardiac surgery within the next 180 days.
• Coronary PTCA/stenting within the previous 180 days.
• Documented left atrial thrombus on ultrasound imaging (TEE).
• Documented history of a thrombo-embolic event within the previous 365 days.
• Diagnosed atrial myxoma.
• Presence of an implanted ICD.
• Presence of permanent pacing leads.
• Significant restrictive, constrictive, or chronic obstructive pulmonary disease or any other disease or malfunction of the lungs or respiratory system with chronic symptoms.
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
• Women who are pregnant.
• Acute illness or active infection at time of index procedure documented by either pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3) for which antibiotics have been or will be prescribed.
• Creatinine > 2.5 mg/dl (or > 221 µmol/L).
• Unstable angina.
• Myocardial infarction within the previous 60 days.
• Left ventricular ejection fraction less than 40%
• History of blood clotting or bleeding abnormalities.
• Contraindication to anticoagulation medications.
• Contraindication to computed tomography or magnetic resonance imaging procedures.
• Life expectancy less than 1 year.
• Enrollment in another investigational study.
• Uncontrolled heart failure (NYHA class III or IV heart failure).
• Presence of an intramural thrombus, tumor, or other abnormality that precludes catheter introduction or positioning.
• Presence of a condition that precludes vascular access.
• Left atrial size ≥ 50mm.
• INR greater than 3.0 within 24 hours of procedure.