Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)

Inclusion criteria

• Age > 18 years.
• Signed the Patient Informed Consent Form (ICF)
• Documented ongoing or previous symptomatic persistent AF (by physician's note indicating continuous AF ≥ 7 days)
• Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion criteria

• Previous surgical or catheter ablation for atrial fibrillation
• Current condition of continuous AF > 12 months (1 year) (Longstanding Persistent AF) or previously diagnosed as having Longstanding Persistent AF
• Any carotid stenting or endarterectomy
• Known with Cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion.
• LA size > 55 mm
• LVEF <40%
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Significant pulmonary disease (i.e. 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
• Uncontrolled heart failure or NYHA function class III and IV
• MI within the past 2 months
• Any cardiac surgery (i.e. CABG) within the past 2 months
• Subjects that have ever undergone valvular cardiac surgical/ percutaneous procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
• Documented thromboembolic event (including TIA) within the past 12 months
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
• Active illness or active systemic infection or sepsis
• Unstable angina
• History of blood clotting or bleeding abnormalities
• Contraindication to anticoagulation (eg, heparin or warfarin)
• Life expectancy less than 12 months
• Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
• Presence of a condition that precludes vascular access
• Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
• Currently enrolled in another device, biologics, or drug study
• Contraindication for use of the investigational devices , as indicated in the respective Instructions For Use