Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 3:18 AM
Study NCT ID:
NCT02839304
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2016-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation
Sponsor:
Adagio Medical
Organization:
Study Overview
Official Title:
A Prospective, Multicenter Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2019-05
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:
CryoCure2
Brief Summary:
The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: