A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)

Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)

The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Inclusion Criteria:

• Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF)
• Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
• Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation AF, or intolerable or contraindicated to the AAD
• Willing and capable of providing consent
• Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria:

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Previous left atrium (LA) ablation or surgery
• Participant known to require ablation outside the PV region (example. cavotricuspid isthmus [CTI] region, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
• Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
• Severe dilatation of the LA (LAD >50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))