A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation

Inclusion Criteria

• Patients with documented drug resistant symptomatic PAF who have:
• Confirmed AF: Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor, implanted devices, telemetry strip or similar, recorded within one year prior to enrollment and showing at least 30 seconds of AF.
• Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment.
• Failed AFD, meaning therapeutic failure of at least one antiarrhythmic drug (AFD; class I - IV) for efficacy and / or intolerance
• 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

• Use of amiodarone within 3 months prior to enrollment
• Atrial fibrillation that is any of the following
• Persistent (by diagnosis or duration > 7 days)
• Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
• Requires ≥ 3 cardioversions in the preceding 12 months
• Cardiac anatomical exclusions by imaging within 3 months prior to enrollment:
• Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
• Left ventricular ejection fraction ≤ 40% as documented by TTE
• Any of the following cardiac procedures, implants or conditions:
• Clinically significant arrhythmias other than AF
• Hemodynamically significant valvular disease
• Prosthetic heart valve
• NYHA Class III or IV CHF
• Previous endocardial or epicardial ablation or surgery for AF
• Atrial or ventricular septal defect closure
• Atrial myxoma
• Left atrial appendage device or occlusion
• Pacemaker, ICD or CRT
• Significant or symptomatic hypotension
• Bradycardia or chronotropic incompetence
• History of pericarditis
• History of rheumatic fever
• Any of the following within 3 months of enrollment:
• Myocardial infarction
• Unstable angina
• Percutaneous coronary intervention
• Heart surgery including coronary artery bypass grafting
• Heart failure hospitalization
• Stroke or TIA
• Clinically significant bleeding
• Pericarditis or pericardial effusion
• Left atrial thrombus
• History of blood clotting or bleeding abnormalities.
• Contraindication to, or unwillingness to use, systemic anticoagulation
• Contraindications to CT or MRI
• Sensitivity to contrast media not controlled by premedication
• Women of childbearing potential who are pregnant, lactating or not using birth control
• Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or its interpretation, including but not limited to
• 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
• Chronic renal insufficiency of < 60 mL/min/1.73 m2, any history of renal dialysis, or history of 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