TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation

Inclusion Criteria: * Plans to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I or III antiarrhythmic drug * Physician's note indicating recurrent self-terminating AF * One electrocardiographically documented AF episode within 6 months prior to the index ablation procedure * At least 18 years of age * Able and willing to comply with all trial requirements * Informed of the nature of the trial, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site. Exclusion Criteria: * Persistent or long-standing persistent atrial fibrillation (AF) * Four or more cardioversions in the past 12 months * Active systemic infection * Known presence of cardiac thrombus * Implanted with implantable cardiac defibrillator (ICD) * Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months * Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months * Left atrial diameter \> 5.0 cm * Left ventricular ejection fraction \< 35% * New York Heart Association (NYHA) class III or IV * Previous left atrial surgical or catheter ablation procedure * Left atrial surgical procedure or incision with resulting scar * Previous …