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ACTIVE NOT RECRUITING
NCT02830152
NA

Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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

DEVICE

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.

DRUG

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