NCT04524364

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-08-23
• Primary completion: 2023-05-09
• Completion: 2023-05-09
• First posted: 2020-08-24
• Last updated: 2025-05-25
• Results posted: 2024-05-14

Locations

13 sites across 8 countries: Austria, Belgium, Canada, Croatia, Czechia, France, Italy, Lithuania

Regulatory

• FDA-regulated device study