At a glance

ClinicalIndex Comparison Record

N/ACompleted· 272 enrolled

Drug / intervention

Pulsed Field Ablation (PFA) Therapydevice

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/NCT04524364

NCT04524364N/ACompleted

Compare CT.gov

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

Biosense Webster, Inc.·interventional·Posted Aug 24, 2020·Updated May 25, 2025

In Brief

A clinical study evaluating Pulsed Field Ablation (PFA) Therapy for Atrial Fibrillation. Completed, enrolled 272 participants across 13 sites in 8 countries.

Detailed Summary

The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAtrial Fibrillation

CountriesAustria, Belgium, Canada, Croatia, Czechia, France, Italy, Lithuania

Collaborators--

Timeline

N/ACompletedFinished

202120222023202420252026

Enrollment StartAug 2020

First PostedAug 2020

Primary CompletionMay 2023

TodayJul 2026

First PostedAug 24, 2020

Enrollment StartAug 23, 2020

Primary CompletionMay 9, 2023

TodayJul 2, 2026

Enrollment to primary: 2.7 yearsPosted 5.9 years ago

Interventions

Pulsed Field Ablation (PFA) Therapydevice

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).