A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF) (AFIRE)

Biosense Webster

Status: Completed

Conditions: Refractory Paroxysmal Atrial Fibrillation

Treatments: Device: Multi-Channel Irreversible Electroporation (IRE) Generator; Device: Multi-Channel Circular IRE Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05552963

BWI202107 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF).

Enrollment: 142 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) (Physician's note indicating recurrent self-terminating atrial fibrillation [AF]). At least one electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), Holter monitor, or telemetry strip
• Failed at least one Class I or Class III antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF, contraindicated or intolerable to both Class I and Class III AAD
• Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements
• Willing and capable of providing consent

Exclusion criteria

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (Example, untreated documented obstructive sleep apnea and acute alcohol toxicity)
• Previous left atrium (LA) ablation or surgery
• Participants known to require ablation outside the pulmonary vein (PV) region (atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White)
• Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
• Severe dilatation of the LA (documented LAD >50 millimeters [mm] antero-posterior diameter by transthoracic echocardiography (TTE) within 6 month prior to enrollment)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

142 participants in 1 patient group

Irreversible Electroporation (IRE) System

Experimental group

Description:

Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation will be treated with the IRE system which includes multi-electrode circular IRE catheter and the multi-channel IRE generator.

Treatment:

Device: Multi-Channel Circular IRE Catheter

Device: Multi-Channel Irreversible Electroporation (IRE) Generator