TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation

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 tricuspid or mitral valve replacement or repair
• •Heart disease in which corrective surgery is anticipated within 6 months
• •Bleeding diathesis or suspected procoagulant state
• •Contraindication to long term antithromboembolic therapy
• •Presence of any condition that precludes appropriate vascular access
• •Renal failure requiring dialysis
• •Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
• •Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
• •Pregnant or nursing
• •Presence of other anatomic or comorbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results
• •Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial
• •Patient is unlikely to survive the protocol follow up period of 12 months
• •Body mass index \> 40 kg/m2
• •Vulnerable subject