Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-27 @ 10:23 AM
Study NCT ID:
NCT05144503
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation
Sponsor:
Medtronic Cardiac Ablation Solutions
Organization:
Study Overview
Official Title:
A Safety and Performance Assessment of the SpherePVI™ Catheter and the Affera Mapping and Ablation System to Treat Paroxysmal Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2025-06
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:
SpherePVI
Brief Summary:
A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.
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?: