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RECRUITING
NCT03642509
NA

Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation

Sponsor: University of Aarhus

View on ClinicalTrials.gov

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

Interventions

DEVICE

Left atrial appendage occlusion

Interventional left atrial appendage occlusion with the Amulet or Watchman device

DRUG

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