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

NACompletedINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

August 23, 2020

Primary Completion Date

May 9, 2023

Study Completion Date

May 9, 2023

Conditions
Atrial Fibrillation
Interventions
DEVICE

Pulsed Field Ablation (PFA) Therapy

Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).

Trial Locations (13)

3500

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt

3600

Ziekenhuis Oost-Limburg Genk Campus Sint-Jan, Genk

4020

Ordensklinikum Linz Elisabethinen, Linz

8000

AZ Sint-Jan Brugge, Bruges

8036

Medical University Graz, Graz

8661

Vilnius University Hospital, Vilnius

9300

OLV Aalst, Aalst

21000

University Hospital Center Split, Split

33600

Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux

70021

"Ospedale Generale Regionale F. Miulli", Acquaviva delle Fonti

N6A 5A5

London Health Sciences Centre, London

ON L3Y 2P9

Southlake Regional Health Centre, Newmarket

150 30 District 5

Nemocnice na Homolce, Prague

All Listed Sponsors
lead

Biosense Webster, Inc.

INDUSTRY

NCT04524364 - A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) | Biotech Hunter | Biotech Hunter