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

Biosense Webster

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: Pulsed Field Ablation (PFA) Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT04524364

BWI_2019_08 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

272 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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))