Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 1:18 PM
Study NCT ID:
NCT06858306
Status:
RECRUITING
Last Update Posted:
2025-11-03
First Post:
2025-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SPHERE Per-AF Post-Approval Study
Sponsor:
Medtronic Cardiac Ablation Solutions
Organization:
Study Overview
Official Title:
SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry
Status:
RECRUITING
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:
None
Brief Summary:
SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.
Detailed Description:
The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9™ Catheter and Affera™ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: