Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06455098
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-07
Brief Title:
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation PAF
Sponsor:
Biosense Webster Inc
Organization:
Biosense Webster Inc
Study Overview
Official Title:
Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE Catheter
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
Yes
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMNY-AF
Brief Summary:
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE pulsed field ablation PFA platform for pulmonary vein isolation PVI in the treatment of participants with symptomatic paroxysmal atrial fibrillation PAF an irregular heart rate that causes abnormal blood flow
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None