Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06213285
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-30
First Post:
2024-01-09
Brief Title:
APPEND-CT Registry
Sponsor:
Aarhus University Hospital
Organization:
University of Aarhus
Study Overview
Official Title:
Cardiac Computed Tomography Following Watchman FLX Left Atrial APPENDage Closure
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
APPEND-CT
Brief Summary:
The APPEND-CT registry is an investigator-driven multicenter retrospective observational database intended to compile cardiac CT follow-up data after Watchman FLX device implantation and function as a platform for answering clinical and research questions within LAAC follow-up The derived studies should support therapeutic decision-making improve risk-stratification in LAAC and help generate hypotheses for potential future clinical intervention trials
Detailed Description:
An investigator-driven multicenter retrospective observational database enrolling patients from high-volume North American and European centers The database will include Watchman FLX implanted patients with a minimum of one follow-up cardiac CT performed within 45-120 days post-procedure Additional timepoints may be entered Cardiac CT scans are to be uploaded and will be analyzed by the core-lab at Aarhus University Hospital
Investigator-reported findings will be systematically reported to the database This includes information on baseline characteristics preprocedural planning implantation details discharge medication follow-up imaging and clinical endpoints of interest
As a minimum investigator-reported endpoints will be collected from patient registries at one-year follow-up by site-investigators Endpoints of interest include ischemic stroke systemic embolism major bleeding mortality device-related thrombosis pericardial effusion vascular complications and device migration
Investigator-reported findings will be systematically reported to the database This includes information on baseline characteristics preprocedural planning implantation details discharge medication follow-up imaging and clinical endpoints of interest
As a minimum investigator-reported endpoints will be collected from patient registries at one-year follow-up by site-investigators Endpoints of interest include ischemic stroke systemic embolism major bleeding mortality device-related thrombosis pericardial effusion vascular complications and device migration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None