Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation

Inclusion Criteria

Study subjects are required to meet all the following inclusion criteria to participate in this study:

• Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:
• Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agent.
• ECG-documented first episode of persistent AF, lasting longer than 7 days but not longer than 365 days
• Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF
• Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
• Patient participation requirements:
• Lives locally
• Is willing and capable of providing Informed Consent to undergo study procedures
• Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

Exclusion Criteria

Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:

• AF that is:
• Paroxysmal (longest AF episode 12 months or that does not respond to cardioversion if 40
• Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
• Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
• Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
• Active malignancy or history of treated cancer within 24 months of enrollment
• Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
• Clinically significant infection
• Predicted life expectancy less than one year
• Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
• Current or anticipated enrollment in any other clinical study
• Employment by FARAPULSE or the same hospital department or office of any investigator, or a family member of any of the preceding groups.