The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation

Key inclusion criteria: Patients are required to meet all the following inclusion criteria to participate in this study:

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

a. Paroxysmal: AF that terminates spontaneously or with intervention within 7 days of onset.

b. 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, EM, Holter monitor or telemetry strip within 12 months of enrollment.

c. Drug failed: Failed AAD treatment, meaning therapeutic failure of at least one (1) AAD (Class I to IV) for efficacy and / or intolerance.

• Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
• Patient who are willing and capable of:
• Providing informed consent to undergo study procedures AND
• Participating in all examinations and follow-up visits and tests associated with this clinical study.

Key exclusion criteria

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

• 1. AF that is any of the following:
• Persistent (both early and longstanding) by diagnosis or continuous duration > 7 days
• Requires four (4) or more direct-current cardioversions in the preceding 12 months
• Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible / non-cardiac causes
• Any of the following atrial conditions:
• Left atrial anteroposterior diameter ≥ 5.5 cm (by MRI, CT or TTE)
• Any prior atrial endocardial or epicardial ablation procedure, other than right sided cavotricuspid isthmus ablation or for right sided SVT
• Any prior atrial surgery
• Intra-atrial septal patch or interatrial shunt
• Atrial myxoma
• Current LA thrombus
• LA appendage closure, device or occlusion, past or anticipated
• Any PV abnormality, stenosis or stenting (common and middle PVs are admissible)
• 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 is symptomatic

ii. Valvular disease causing or exacerbating congestive heart failure

iii. Aortic stenosis: if already characterized, valve area 20 mm Hg

iv. Mitral stenosis: if already characterized, valve area 5 mm Hg

v. Aortic or mitral regurgitation associated with abnormal LV function or hemodynamic measurements

c. Hypertrophic cardiomyopathy

d. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty

e. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices

f. Any inferior vena cava (IVC) filter, known inability to obtain vascular access or other contraindication to femoral access

g. History of rheumatic fever

h. History of congenital heart disease with any residual anatomic or conduction abnormality

• Any of the following procedures, implants or conditions:
• At baseline:

i. New York Heart Association (NYHA) Class III/IV

ii. Left ventricular ejection fraction (LVEF) 160 mmHg or DBP > 95 mmHg on two BP measurements at baseline assessment)

v. Symptomatic resting bradycardia

vi. Implantable loop recorder or insertable cardiac monitor,

b. Within the 3 months preceding the Consent Date:

i. Myocardial infarction

ii. Unstable angina

iii. Percutaneous coronary intervention

iv. Heart failure hospitalization

v. Treatment with amiodarone

vi. Pericarditis or symptomatic pericardial effusion

vii. Gastrointestinal bleeding

c. Within the 6 months preceding the Consent Date:

i. Heart surgery

ii. Stroke, TIA or intracranial bleeding

iii. Any thromboembolic event

iv. Carotid stenting or endarterectomy

• Diagnosed disorder of blood clotting or bleeding diathesis
• Contraindication to, or unwillingness to use, systemic anticoagulation
• Patient who is not on anticoagulation therap