Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2025-12-31 @ 7:31 PM
Study NCT ID:
NCT02355106
Status:
COMPLETED
Last Update Posted:
2019-05-22
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicenter, Investigation of the Adagio Cryoablation System in Subjects With Atrial Flutter
Sponsor:
Adagio Medical
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Investigation of the Adagio PolarStar System in Subjects With Atrial Flutter
Status:
COMPLETED
Status Verified Date:
2017-12
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:
The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: