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RECRUITINGINTERVENTIONAL

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

Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation. A Multicenter Randomized Clinical Trial. (Occlusion-AF)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥ 18 years - documented non-valvular atrial fibrillation (paroxysmal, persistent or permanent) - Eligible for long-term Novel Oral Anticoagulation (NOAC) therapy - Ischemic stroke within the recent 6 months verified by neuroimaging, or - Transient ischemic attack within 6 months with proven cerebral ischemia based on cerebral magnetic resonance imaging (MRI) Who Should NOT Join This Trial: - Modified rankin scale \> 3 at time of enrollment - Glomerular filtration rate (GFR) below 15 ml/min/1.73 m2 - Contraindication towards long-term aspirin therapy - Planned combined cardiovascular interventional procedures at the time of enrollment - Terminal illness or cancer with life expectancy less than 2 years. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age ≥ 18 years * documented non-valvular atrial fibrillation (paroxysmal, persistent or permanent) * Eligible for long-term Novel Oral Anticoagulation (NOAC) therapy * Ischemic stroke within the recent 6 months verified by neuroimaging, or * Transient ischemic attack within 6 months with proven cerebral ischemia based on cerebral magnetic resonance imaging (MRI) Exclusion Criteria: * Modified rankin scale \> 3 at time of enrollment * Glomerular filtration rate (GFR) below 15 ml/min/1.73 m2 * Contraindication towards long-term aspirin therapy * Planned combined cardiovascular interventional procedures at the time of enrollment * Terminal illness or cancer with life expectancy less than 2 years.

Treatments Being Tested

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