Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170606
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-12-06
Brief Title:
POLARx Post Approval Study POLARx PAS
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Prospective Multi-Site Safety and Effectiveness Study of the Boston Scientific Cardiac Cryoablation System for Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
To collect clinical data on safety effectiveness and procedural success of Boston Scientifics Cardiac Cryoablation System includes all BSC commercially available POLARxPOLARx Fit catheters when used to perform pulmonary vein isolation PVI in the ablation treatment of de novo Atrial Fibrillation AF
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?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None