CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled
Drug / intervention
Multi-Channel Irreversible Electroporation (IRE) Generator +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05552963
NCT05552963N/ACompleted
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A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Multi-electrode Circular IRE Catheter and Multi-Channel IRE Generator in Paroxysmal AF

Biosense Webster, Inc.·interventional·Posted Sep 23, 2022·Updated Jan 6, 2026

In Brief

A clinical study evaluating Multi-Channel Irreversible Electroporation (IRE) Generator and Multi-Channel Circular IRE Catheter for Refractory Paroxysmal Atrial Fibrillation. Completed, enrolled 142 participants across 6 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Paroxysmal Atrial Fibrillation
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 23, 2022
Enrollment StartDec 7, 2022
Primary CompletionDec 18, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 3.8 years ago

Interventions

Multi-Channel Irreversible Electroporation (IRE) Generatordevice

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.

Multi-Channel Circular IRE Catheterdevice

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.