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

NACompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

December 7, 2022

Primary Completion Date

December 18, 2024

Study Completion Date

December 18, 2024

Conditions
Refractory Paroxysmal Atrial Fibrillation
Interventions
DEVICE

Multi-Channel Irreversible Electroporation (IRE) Generator

The multi-channel IRE Generator is intended for use during cardiac Pulsed Field Ablation (PFA) therapy. This device is used in conjunction with a compatible ablation catheter to create a closed electrical circuit capable of delivering pulsed electrical field energy.

DEVICE

Multi-Channel Circular IRE Catheter

The multi-channel circular IRE Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and when used with an IRE Generator, for cardiac ablation.

Trial Locations (6)

Unknown

Guangdong Provincial People's Hospital, Guangzhou

The first affiliated hospital of Zhengzhou University, Zhengzhou

The first affiliated hospital of Dalian Medical University, Dalian

Shanghai General Hospital, Shanghai

West China Hospital of Sichuan University, Chengdu

Tianjin Medical University General Hospital, Tianjin

All Listed Sponsors
lead

Biosense Webster, Inc.

INDUSTRY