Ground-Breaking Electroporation-based Intervention for PAROXysmal Atrial Fibrillation Treatment (BEAT PAROX-AF)

Inclusion Criteria:

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

2. Paroxysmal: AF that terminates spontaneously or with intervention within 7 daysof onset.

3. Frequency: i. Physician documentation of recurrent PAF (two or more episodes) within 6 months,AND ii. At least one (1) documented episode by a recording such as ECG, EventMonitor, Holter monitor or telemetry strip within 12 months of enrolment. c. Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance.

4. Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.

5. Patient who are willing and capable of:

6. Providing informed consent to undergo study procedures AND

7. Participating in all examinations and follow-up visits and tests associatedwith this clinical study.

8. Patient having a smart phone compatible with the Event Monitor device.

9. Effective contraception for women of childbearing potential.

10. Effective oral anticoagulation >3 weeks prior to planned ablation procedure

11. Patient affiliated to or beneficiary of national health security scheme for Frenchparticipants.

Exclusion Criteria:

1. AF that is any of the following:

2. Persistent (both early and longstanding) by diagnosis or continuous duration > 7 days

3. Secondary to electrolyte imbalance, thyroid disease, alcohol or otherreversible / non-cardiac causes 2. Any of the following atrial conditions:

4. Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or TTE)

5. Any prior atrial endocardial or epicardial ablation procedure, other than rightsided cavotricuspid isthmus ablation or for right sided SVT

6. Any prior atrial surgery

7. Intra-atrial septal patch or interatrial shunt

8. Atrial myxoma

9. Current LA thrombus

10. LA appendage closure, device or occlusion, past or anticipated

11. Any PV abnormality, stenosis or stenting (common and middle PVs are admissible)

12. At any time, one (1) or more of the following cardiovascular procedures,implants or conditions: a. Sustained ventricular tachycardia or any ventricular fibrillation b.Hemodynamically significant valvular disease: i. Valvular disease that issymptomatic ii. Valvular disease causing or exacerbating congestive heart failureiii. Aortic stenosis: if already characterized, valve area < 1.5cm or gradient > 20mm Hg iv. Mitral stenosis: if already characterized, valve area < 1.5cm or gradient > 5 mm Hg v. Aortic or mitral regurgitation associated with abnormal LV function orhemodynamic measurements c. Hypertrophic cardiomyopathy d. Any prosthetic heartvalve, ring or repair including balloon aortic valvuloplasty e. Pacemaker,implantable cardioverter defibrillator or cardiac resynchronization therapy devicesf. Any inferior vena cava (IVC) filter, known inability to obtain vascular access orother contraindication to femoral access g. History of rheumatic fever h. History ofcongenital heart disease with any residual anatomic or conduction abnormality 4. Anyof the following procedures, implants or conditions: a. At baseline: i. New York Heart Association (NYHA) Class III/IV ii. Leftventricular ejection fraction (LVEF) < 40% iii. Symptomatic hypotension iv.Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two BP measurements atbaseline assessment) v. Symptomatic resting bradycardia vi. Implantable looprecorder or insertable cardiac monitor, b. Within the 3 months preceding the ConsentDate: i. Myocardial infarction ii. Unstable angina iii. Percutaneous coronaryintervention iv. Heart failure hospitalization v. Pericarditis or symptomaticpericardial effusion vi. Gastrointestinal bleeding c. Within the 6 months precedingthe Consent Date: i. Heart surgery ii. Stroke, TIA or intracranial bleeding iii. Anythromboembolic event iv. Carotid stenting or endarterectomy 5. Diagnosed disorder ofblood clotting or bleeding diathesis 6. Contraindication to, or unwillingness touse, systemic anticoagulation 7. Contraindication to both CT and MRI 8. Sensitivityto contrast media not controllable by premedication 9. Women of childbearingpotential who are pregnant, lactating, not using medical birth control or who areplanning to become pregnant during the anticipated study period 10. Medicalconditions that would prevent participation in the study, interfere with assessmentor therapy, significantly raise the risk of study participation, or modify outcomedata or its interpretation, including but not limited to:

13. Body Mass Index (BMI) > 40.0

14. Solid organ or hematologic transplant, or currently being evaluated for anorgan transplant

15. Severe lung disease, pulmonary hypertension, or any lung disease involvingabnormal blood gases or requiring supplemental oxygen

16. Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30mL/min/1.73 m2, or any history of renal dialysis or renal transplant

17. Active malignancy or history of treated malignancy within 24 months ofenrollment (other than cutaneous basal cell or squamous cell carcinoma)

18. Clinically significant gastrointestinal problems involving the esophagus orstomach including severe or erosive esophagitis, uncontrolled gastric reflux,gastroparesis, esophageal candidiasis or active gastroduodenal ulceration

19. Active systemic infection

20. COVID-19 disease

21. Current confirmed, active COVID-19 disease ii. Current positive test forSARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3months prior to the Consent Date. i. Other uncontrolled medical conditions that may modify device effect or increaserisk, including uncontrolled diabetes mellitus (HgbA1c > 8.0% if test result alreadyobtained), untreated obstructive sleep apnea or active alcohol abuse j. Predictedlife expectancy less than one (1) year 11. Clinically significant psychologicalcondition that in the Investigator's opinion would prohibit the subject's ability tomeet the protocol requirements/ Patient under legal protection 12. Current oranticipated enrollment in any other clinical study. 13. Employees / family membersof:

22. FARAPULSE or any of its affiliates or contractors

23. The Investigator, sub-Investigators, or their medical office or practice, orhealthcare organizations at which study procedures may be performed.