The FARAPULSE PersAFOne III Trial for 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 prior to 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

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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.
• Use of amiodarone after day of index ablation procedure. Patients will cease use of amiodarone on or before the date of the index ablation procedure.

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