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

Sponsor
Biosense Webster, Inc.
Study ID
NCT05971693
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator — DEVICE
    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).

Study Details

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).

Key Dates

Start date
Sep 12, 2023
Status verified
Mar 2026
Primary completion
Dec 10, 2024
Completion
Sep 5, 2025

Study Design

Enrollment
188 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
    Participants with symptomatic paroxysmal atrial fibrillation (PAF) will undergo the ablation procedure with OMNYPULSE bi-directional catheter used in combination with the TRUPULSE generator for pulmonary vein isolation (PVI).

Primary Outcome Measure

Percentage of Participants With Primary Adverse Events (PAEs) [ Time Frame: 90 days post catheter insertion on Day 0 ]

Related Studies