Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation.
- At least two symptomatic AF episodes within last six months from enrollment.
- At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment.
- Failed at least one Class I or Class III antiarrhythmic drug.
- Age 18 -75 years old.
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous surgical or catheter ablation for AF.
- Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF > 7 days.
- Any percutaneous coronary intervention within the past 2 months.
- Valve repair or replacement or presence of a prosthetic valve.
- Any carotid stenting or endarterectomy within the past 6 months.
- Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months.
- Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
- LA antero posterior diameter > 50 mm.
- Left Ventricular Ejection Fraction (LVEF) < 40%.
- Contraindication to anticoagulation (e.g., heparin).
- Myocardial infarction within the past 2 months.
- Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
- Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
- Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
- Life expectancy or other disease processes likely to limit survival to less than 12 months.