Atrial Fibrillation Device thrombosis post-Left Atrial Appendage Closure
Conditions
Brief summary
Primary Efficacy Endpoint: Device thrombosis as evaluated by TEE 60 days after LAAC and analyzed in a central echo core lab (as-treated analysis), Primary Safety Endpoint :Adverse clinical events including all-cause mortality, stroke, bleeding, or device thrombosis* within 60 days after LAAC (intention-to-treat analysis) * As clinically evaluated and diagnosed by the center investigators and determining a treatment change
Detailed description
Device thrombosis as evaluated by TEE or computed tomography 12 months after LAAC, Ischemic events (stroke, TIA) at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up, Bleeding events at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up
Interventions
DRUGDabigatran Etexilate GLN 150 mg hard capsules
DRUGASPIRINE ARROW 75 mg
DRUGApixaban Teva GmbH 5 mg filmdragerade tabletter
DRUGEdoxaban TAD 60 mg apvalkotās tabletes
DRUGRivaroxaban Kéri 20 mg filmtabletta
Sponsors
Centre Hospitalier Universite De Laval
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint: Device thrombosis as evaluated by TEE 60 days after LAAC and analyzed in a central echo core lab (as-treated analysis), Primary Safety Endpoint :Adverse clinical events including all-cause mortality, stroke, bleeding, or device thrombosis* within 60 days after LAAC (intention-to-treat analysis) * As clinically evaluated and diagnosed by the center investigators and determining a treatment change | — |
Secondary
| Measure | Time frame |
|---|---|
| Device thrombosis as evaluated by TEE or computed tomography 12 months after LAAC, Ischemic events (stroke, TIA) at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up, Bleeding events at 2-months and 1-, 2-, 3-, 4-, 5-year follow-up | — |
Countries
Spain
Outcome results
None listed