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

Launched by BIOSENSE WEBSTER, INC. · Aug 21, 2020

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ALL

Eligibility criteria

• 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))