NCT05971693

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-09-12
• Primary completion: 2024-12-10
• Completion: 2025-09-05
• First posted: 2023-08-02
• Last updated: 2026-03-25
• Results posted: 2026-03-25

Locations

13 sites across 8 countries: Belgium, Canada, Croatia, Czechia, Germany, Italy, Lithuania, Netherlands

Regulatory

• FDA-regulated device study