Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation

Inclusion criteria

• Patient must provide written informed consent prior to any clinical investigation related procedure.
• Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7-days and less than 1-year that is documented by (1) a physician's note and (2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF
• Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF
• Age 18 years or older
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion criteria

• Continuous AF > 12 months (longstanding persistent AF)
• Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar
• Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial procedure
• CABG surgery within the 6-months (180-days) prior to the initial procedure
• Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve)
• Any carotid stenting or endarterectomy
• Documented or known left atrial thrombus on imaging
• Left atrial diameter > 50 mm (parasternal long axis view or by CT)
• Left ventricular ejection fraction < 40%
• Unable to take anticoagulation medication due to contraindication or intolerance
• History of blood clotting or bleeding abnormalities
• Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI) within the 3-months (90-days) prior to the initial procedure
• Documented thromboembolic event (including TIA) within the 12-months (365 days) prior to the initial procedure
• Rheumatic heart disease
• Uncontrolled heart failure or NYHA functional class III or IV
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
• Awaiting cardiac transplantation or other cardiac surgery within the 12-months (365 days) following the initial ablation procedure
• Unstable angina at the time of the initial procedure
• Acute illness or active systemic infection or sepsis
• AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, major surgical procedure in the preceding 3-months, or other reversible or non-cardiac cause
• Diagnosed atrial myxoma
• Presence of implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
• Significant 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 chronic symptoms
• Significant congenital anomaly or other anatomic or comorbid medical problem that in the opinion of the investigator would preclude enrollment in this study or compliance with the follow-up requirements or impact the scientific soundness of the clinical trial results
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
• Enrollment in an investigational study evaluating another device, biologic, or drug that may interfere with this clinical investigation at the time of the initial procedure or within 30 days prior to the initial procedure
• Presence of any condition that precludes appropriate vascular access or manipulation of catheter
• Life expectancy less than 12-months
• Body mass index > 40 kg/m2
• Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
• Renal failure requiring dialysis
• Vulnerable subject
• History of atriotomy or ventriotomy
• Implanted endocardial left atrial appendage occlusion device