Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449469
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2023-07-04
Brief Title:
The Nordic Aortic Valve Intervention Trial 4 NOTION-4
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Prospective Study on the Impact of Different Anti-thrombotic Therapies on Subclinical Leaflet Thickening and Its Temporal Dynamics in Transcatheter Bioprosthetic Aortic Valves NOTION-4
Status:
RECRUITING
Status Verified Date:
2024-06
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:
NOTION-4
Brief Summary:
A randomized clinical trial investigating the incidence and temporal dynamics of subclinical leaflet thickening by cardiac CT in transcatheter bioprosthetic aortic valves in patients randomised to different anti-thrombotic strategies Additionally this study aims to examine a possible association between HALT and thromboembolic events
Detailed Description:
The NOTION-4 trial is an investigator-initiated randomized open label comparative trial conducted at Rigshospitalet in Copenhagen and Skejby Sygehus in Aarhus All adult patients that have undergone successful TAVI without contraindications for cardiac CT will be invited to participate in this study Patients with SR and without known other indication for chronic OAC therapy will be randomized 11 either to lifelong ASA or to 3 months of DOAC followed by lifelong ASA Patients with known AF will be randomized 11 to lifelong DOAC versus LAAC within 3 months followed by lifelong ASA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003361-19 | EUDRACT_NUMBER | None | None |