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

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:
4. Lives locally.
5. Is willing and capable of providing Informed Consent to undergo study procedures.
6. 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:
2. Persistent
3. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
4. Longstanding
5. Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
6. Any of the following cardiac procedures, implants or conditions:
7. Clinically significant arrhythmias other than AF, AFL or AT
8. Previous endocardial or epicardial ablation or surgery for AF
9. Hemodynamically significant valvular disease
10. Prosthetic heart valve
11. Heart Failure for example NYHA Class III or IV CHF, LVEF <40%, Heart failure hospitalization
12. Atrial or ventricular septal defect closure
13. Atrial myxoma
14. Left atrial thrombus
15. Left atrial appendage device or occlusion
16. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
17. Significant or symptomatic hypotension
18. Bradycardia or chronotropic incompetence
19. History of pericarditis
20. History of rheumatic fever
21. History of congenital heart disease with any residual anatomic or conduction abnormality
22. Any pulmonary vein abnormality, stenosis or stenting
23. Any of the following cardiovascular procedures, implants, or conditions:
24. Within the 3 months preceding enrollment:
25. Myocardial infarction ii. Unstable angina iii. Percutaneous coronary intervention iv. Treatment with amiodarone
26. Within the 6 months preceding enrollment:
27. Heart surgery ii. Stroke or TIA iii. Any thromboembolic event iv. Carotid stenting or endarterectomy
28. Pericarditis or pericardial effusion
29. Within the 12 months following enrollment:
30. Any likelihood of cardiac surgery or transplant
31. History of blood clotting or bleeding abnormalities.
32. Contraindication to, or unwillingness to use, systemic anticoagulation
33. Contraindications to both CT and MRI
34. Sensitivity to contrast media not controlled by premedication
35. Women of childbearing potential who are pregnant, lactating, not using birth control or planning to become pregnant during the anticipated study period
36. 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
37. Body mass index (BMI) > 40
38. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
39. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
40. Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
41. Active malignancy or history of treated cancer within 24 months of enrollment
42. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
43. Clinically significant infection
44. Predicted life expectancy less than one year
45. Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
46. Current or anticipated enrollment in any other clinical study