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Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage
Sponsor: Karolinska Institutet
Summary
Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses a particular dilemma for thromboprophylaxis. Left atrial appendage occlusion (LAAO) is a non-pharmacological approach to prevent cardiac embolism in NVAF. The risk-benefit ratio of LAAO in patients with NVAF after ICH is unknown. The aim of STROKECLOSE is to assess the effect of LAAO to reduce the incidence stroke, bleeding and cardiovascular mortality in patients with NVAF and prior ICH.
Official title: Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage: A Multicenter Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2017-05-03
Completion Date
2028-12
Last Updated
2024-06-12
Healthy Volunteers
No
Interventions
LAAO
The left atrial appendage is occluded with the AMPLATZER™ Amulet™ device, which offers a conformable disc and lobe designed for complete occlusion of the left atrial appendage.
Medical Therapy
Available options included in Medical therapy are: anticoagulation with OAC or NOAC, antiplatelet therapy (including monotherapy and dual antiplatelet therapy) and no pharmacological antithrombotic therapy.
Locations (17)
Aarhus University Hospital
Aarhus, Denmark
Bispebjerg University Hospital
Bispebjerg, Denmark
Rikshospitalet Glostrup
Glostrup Municipality, Denmark
Herlev sjukhus
Herlev, Denmark
Odenses Universitetssjukhus
Odense, Denmark
Helsinki University Hospital
Helsinki, Finland
North Karelia Central Hospital
Joensuu, Finland
Kuopio University Hospital
Kuopio, Finland
Turku University Hospital
Turku, Finland
Vaasa Centralsjukhus
Vaasa, Finland
Haukeland Universitetssjukhus
Bergen, Norway
Oslo University Hospital
Oslo, Norway
Sahlgrenska University Hospital
Gothenburg, Sweden
Universitetssjukhuset Skåne
Lund, Sweden
Universitetssjukhuset
Örebro, Sweden
Danderyd Hospital
Stockholm, Sweden
Akademiska sjukhuset
Uppsala, Sweden