Ignite Creation Date:
2025-12-18 @ 8:36 AM
Ignite Modification Date:
2025-12-23 @ 7:05 PM
Study NCT ID:
NCT01408485
Status:
None
Last Update Posted:
2019-02-15 00:00:00
First Post:
2011-07-22 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter
Sponsor:
None
Organization:
Study Overview
Official Title:
Clinical Evaluation of Therapy™ Cool Flex™ Irrigated Ablation System for the Treatment of Typical Atrial Flutter
Status:
None
Status Verified Date:
2019-01
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:
FLEXION-AFL
Brief Summary:
This will be a prospective, multi-center and non-randomized study. All treated patients will receive ablation therapy for typical atrial flutter using the TherapyTM Cool FlexTM Irrigated Ablation System. Historical data from combined published (PMA P060019 Cool Path) and reported (IDE G090109 Cool Path Duo) Atrial Flutter studies will be used to determine performance goals for study endpoints.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: