A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation

FARA-Free: A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation

The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial fibrillation (PAF).

This is a prospective, multi-center, single arm safety and effectiveness pilot study. Subjects will undergo percutaneous PFA ablation for pulmonary vein isolation and at the clinical discretion of the investigator receive PFA ablation of additional arrhythmogenic locations. Subjects will be followed at 7 days (telephonic), 30 days, 90 days, 6 months and 12 months for adverse events, recurrence of arrhythmia after a 90-day Blanking Period and other relevant outcome measures.

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

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

1. AF that is:

   1. Persistent
   2. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
   3. Longstanding

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. Previous endocardial or epicardial ablation or surgery for AF
   3. Hemodynamically significant valvular disease
   4. Prosthetic heart valve
   5. Heart Failure for example NYHA Class III or IV CHF, LVEF <40%, Heart failure hospitalization
   6. Atrial or ventricular septal defect closure
   7. Atrial myxoma
   8. Left atrial thrombus
   9. Left atrial appendage device or occlusion
   10. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
   11. Significant or symptomatic hypotension
   12. Bradycardia or chronotropic incompetence
   13. History of pericarditis
   14. History of rheumatic fever
   15. History of congenital heart disease with any residual anatomic or conduction abnormality
   16. Any pulmonary vein abnormality, stenosis or stenting

4. Any of the following cardiovascular procedures, implants, or conditions:

   a. Within the 3 months preceding enrollment:

   i. Myocardial infarction

   ii. Unstable angina

   iii. Percutaneous coronary intervention

   iv. Treatment with amiodarone

   b. Within the 6 months preceding enrollment:

   i. Heart surgery

   ii. Stroke or TIA

   iii. Any thromboembolic event

   iv. Carotid stenting or endarterectomy

   v. Pericarditis or pericardial effusion

   c. Within the 12 months following enrollment:

   i. Any likelihood of cardiac surgery or transplant

5. History of blood clotting or bleeding abnormalities.

6. Contraindication to, or unwillingness to use, systemic anticoagulation

7. Contraindications to both CT and MRI

8. Sensitivity to contrast media not controlled by premedication

9. Women of childbearing potential who are pregnant, lactating, not using birth control or planning to become pregnant during the anticipated study period

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