Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521463
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
SIMPLAAFY Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
WATCHMAN FLX Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMPLAAFY
Brief Summary:
The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet DAPT therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting
Detailed Description:
This study is a prospective randomized open-label triple-arm multi-center trial Subjects will be randomized 111 to one of the three therapy arms and remain on treatment through the end of study 12 months
1 Aspirin only
2 Reduced dose non-vitamin K antagonist VKA oral anticoagulant NOAC
3 DAPT
1 Aspirin only
2 Reduced dose non-vitamin K antagonist VKA oral anticoagulant NOAC
3 DAPT
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?:
None