Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
Study NCT ID:
NCT05971693
Status:
COMPLETED
Last Update Posted:
2025-10-14
First Post:
2023-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
Sponsor:
Biosense Webster, Inc.
Organization:
Study Overview
Official Title:
Safety and Effectiveness Evaluation of the OMNYPULSE Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Omny-IRE
Brief 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BWI202201 | OTHER | Biosense Webster, Inc. | View |