NCT05971693 - A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator | Biotech Hunter

Enrollment

188

Participants

Timeline

Start Date

September 12, 2023

Primary Completion Date

December 10, 2024

Study Completion Date

September 5, 2025

Conditions

Atrial Fibrillation

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).

Trial Locations (13)

3500

Jessa Ziekenhuis - Campus Virga Jesse, Hasselt

3600

Ziekenhuis Oost-Limburg, Genk

8000

AZ Sint-Jan, Bruges

9300

AZORG campus Aalst Moorselbaan, Aalst

21000

KBC Split, Split

60431

MVZ CCB Frankfurt und Main Taunus GbR, Frankfurt a.M.

70021

Generale Regionale F. Miulli, Acquaviva delle Fonti

H1T 1C8

Montreal Heart Institute, Montreal

H3G 1A4

McGill University Health Centre, Montreal

140 21

IKEM, Prague

150 30 District 5

Nemocnice na Homolce, Prague

08661

Vilnius University Hospital Santariskiu Klinikos, Vilnius

6229 HX

Maastricht UMC, Maastricht

All Listed Sponsors

lead

Biosense Webster, Inc.

INDUSTRY