Clinical Research Directory
Browse clinical research sites, groups, and studies.
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation
Sponsor: University of Aarhus
Summary
Atrial fibrillation (AF) is progressively common, and increases the risk of stroke five-fold. Oral anticoagulation is the mainstay therapy; however, it increases the risk of bleeding. Moreover, 30% with AF and at risk of stroke are not in relevant anticoagulation. The randomized PROTECT-AF trial has demonstrated the superiority of left atrial appendage occlusion (LAAO) as compared to warfarin for prevention of the combined endpoint of stroke, major bleeding and cardiovascular mortality. However, studies comparing LAAO to therapy with novel oral anticoagulants (NOAC) have not been carried out. This study aims to assess the effect of left atrial appendage occlusion (LAAO) to reduce the incidence of stroke, systemic embolism, major bleeding and all-cause mortality in patients with atrial fibrillation (AF) and a prior ischemic stroke or transient ischemic attack (TIA).
Official title: Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation. A Multicenter Randomized Clinical Trial. (Occlusion-AF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2019-01-01
Completion Date
2030-10-01
Last Updated
2023-12-21
Healthy Volunteers
No
Conditions
Interventions
Left atrial appendage occlusion
Interventional left atrial appendage occlusion with the Amulet or Watchman device
NOAC
Medical treatment arm. Patients will be treated with one of the available NOAC drugs; Apixaban, Dabigatran, Edoxaban or Rivaroxaban. The specific drug and dose is at the discretion of the treating physician.
Locations (15)
Aarhus University Hospital
Aarhus, Central Jutland, Denmark
Odense University Hospital
Odense, Region Syddanmark, Denmark
Aalborg University Hospital
Aalborg, The North Denmark Region, Denmark
Rigshospitalet
Copenhagen, Denmark
Regional Hospital West Jutland
Holstebro, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Oulu University Hospital
Oulu, Finland
Turku University Hospital
Turku, Finland
Jena University Hospital
Jena, Germany
Haukeland University Hospital
Bergen, Norway
Oslo University Hospital
Oslo, Norway
Trondheim University Hospital
Trondheim, Norway
Sahlgrenska University Hospital
Gothenburg, Sweden
Skånes University Hospital
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden