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COMPLETED
NCT05971693
NA

A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator

Sponsor: Biosense Webster, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Official title: Safety and Effectiveness Evaluation of the OMNYPULSE Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

188

Start Date

2023-09-12

Completion Date

2025-09-05

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DEVICE

OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator

Participants will undergo catheter ablation with the PF ablation system consisting of the TRUPULSE generator (delivers PF energy through the study catheter) and the OMNYPULSE bi-directional catheter (indicated for use in catheter-based cardiac electrophysiological mapping \[stimulating and recording\] and, when used with a Generator, for cardiac ablation).

Locations (13)

AZORG campus Aalst Moorselbaan

Aalst, Belgium

AZ Sint-Jan

Bruges, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Belgium

Montreal Heart Institute

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

KBC Split

Split, Croatia

IKEM

Prague, Czechia

Nemocnice na Homolce

Prague, Czechia

MVZ CCB Frankfurt und Main Taunus GbR

Frankfurt a.M., Germany

Generale Regionale F. Miulli

Acquaviva delle Fonti, Italy

Vilnius University Hospital Santariskiu Klinikos

Vilnius, Lithuania

Maastricht UMC

Maastricht, Netherlands