PEFCATII Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation

PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat Paroxysmal Atrial Fibrillation

This is a prospective, multi-center, safety and feasibility study. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PEF ablation of additional arrhythmogenic locations. Subjects will be followed at 30 days, 75 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.

Eligibility Criteria:
Inclusion Criteria:

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

1. Patients with documented drug-resistant symptomatic PAF meeting all three of the following criteria:

   1. Confirmed AF: Documentation must include a recording such as ECG, transtelephonic monitor (TTM), Holter monitor, implanted devices, or telemetry strip, recorded within one year prior to enrollment and showing at least 30 seconds of AF.
   2. Frequent AF, defined as ≥ 2 episodes within 6 months of enrollment.
   3. Failed atrial fibrillation drug (AFD) treatment, meaning therapeutic failure of at least one AFD (class I - IV) for efficacy and / or intolerance.
2. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
3. Patient participation requirements:

   1. Lives locally.
   2. Is willing and capable of providing Informed Consent to undergo study procedures.
   3. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

Exclusion Criteria:

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

1. Atrial fibrillation that is any of the following:

   1. Persistent (by diagnosis or duration \> 7 days)
   2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
   3. Requires ≥ 4 cardioversions in the preceding 12 months
2. Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
3. Any of the following cardiac procedures, implants or conditions:

   1. Clinically significant arrhythmias other than AF, AFL or AT
   2. Hemodynamically significant valvular disease
   3. Prosthetic heart valve
   4. NYHA Class III or IV CHF
   5. Previous endocardial or epicardial ablation or surgery for AF
   6. Atrial or ventricular septal defect closure
   7. Atrial myxoma
   8. Left atrial appendage device or occlusion
   9. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
   10. Significant or symptomatic hypotension
   11. Bradycardia or chronotropic incompetence
   12. History of pericarditis
   13. History of rheumatic fever
   14. History of congenital heart disease with any residual anatomic or conduction abnormality
4. Any of the following within 3 months of enrollment:

   1. Myocardial infarction
   2. Unstable angina
   3. Percutaneous coronary intervention
   4. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)
   5. Heart failure hospitalization
   6. Stroke or TIA
   7. Clinically significant bleeding
   8. Pericarditis or pericardial effusion
   9. Left atrial thrombus
5. History of blood clotting or bleeding abnormalities
6. Contraindication to, or unwillingness to use, systemic anticoagulation
7. Contraindications to CT or MRI
8. Sensitivity to contrast media not controlled by premedication
9. Women of childbearing potential who are pregnant, lactating or not using birth control
10. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:

    1. Body mass index (BMI) \> 40
    2. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
    3. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
    4. Renal insufficiency with an estimated creatinine clearance \< 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
    5. Active malignancy or history of treated cancer within 24 months of enrollment
    6. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
    7. Clinically significant infection
    8. Predicted life expectancy less than one year
11. Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements.
12. Current or anticipated enrollment in any other clinical study.