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

NCT05552963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-01-06

Study results available
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Summary

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).

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.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Jianzeng Dong · The First Affiliated Hospital of Zhengzhou University

  • Shaowen Liu · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  • Hailong Tao · The First Affiliated Hospital of Zhengzhou University

  • Hua Fu · West China Hospital

  • Yumei Xue · Guangdong Provincial People's Hospital

  • Heng Cai · Tianjin Medical University General Hospital

  • Lianjun Gao · The First Affiliated Hospital of Dalian Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-07
Primary Completion
2024-12-18
Completion
2024-12-18
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05552963 on ClinicalTrials.gov