Safety and Effectiveness of STSF Catheter Evaluated for Treating Symptomatic Persistent Atrial Fibrillation (PsAF)

Inclusion Criteria

Candidates for this study must meet ALL of the following criteria:

• Documented symptomatic persistent AF, which is defined as continuous AF sustains beyond 7 days and less than 1 year and is documented by the following:.
• Physician's note indicating continuous AF ≥ 7 days but no more than 1 year; AND
• Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR
• 24-hour Holter within 90 days of the ablation procedure showing continuous AF
• Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
• Age 18 years or older.
• Signed Patient Informed Consent Form (ICF).
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria

Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:

• Continuous AF > 12 months (1-Year) (Longstanding Persistent AF)
• Previous surgical or catheter ablation for atrial fibrillation
• Any cardiac surgery within the past 2 months (60 days) (includes percutaneous coronary intervention (PCI))
• Coronary Artery Bypass Graft (CABG) surgery within the past 6 months (180 days)
• Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
• Any carotid stenting or endarterectomy
• Documented left atrial (LA) thrombus on imaging
• LA size > 50 mm (parasternal long axis view)
• Left ventricular ejection fraction (LVEF) < 40%
• Contraindication to anticoagulation (heparin or warfarin)
• History of blood clotting or bleeding abnormalities
• MI within the past 2 months (60 days)
• Documented thromboembolic event (including Transient Ischemic Attack (TIA) within the past 12 months (365 days)
• Rheumatic Heart Disease
• Uncontrolled heart failure or New York Heart Association (NYHA) function 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 next 12 months (365 days)
• Unstable angina
• Acute illness or active systemic infection or sepsis
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Diagnosed atrial myxoma.
• Presence of implanted implantable cardioverter defibrillator (ICD) /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.
• Gastroesophageal Reflux Disease (GERD; active requiring significant intervention not including over-the-counter (OTC) medication)
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
• Enrollment in an investigational study evaluating another device, biologic, or drug.
• Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
• Presence of any other condition that precludes appropriate vascular access.
• Life expectancy less than 12 months