Heart Device Closure Versus Blood-Thinning Pills for Stroke Prevention in Atrial Fibrillation
Compares a heart device closing the left atrial appendage with blood thinners in atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation
Key facts
- Where
- Bergen, Oslo, and Trondheim, NorwaySee the 3 sites
Where in Norway
- Haukeland University HospitalBergen, NorwayTaking people
- Oslo University HospitalOslo, NorwayTaking people
- Trondheim University HospitalTrondheim, NorwayNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT03642509
- Record updated
- 21 December 2023
- Original description
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.Read full original descriptionShow less
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation. A Multicenter Randomized Clinical Trial. (Occlusion-AF)
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).
Inclusion: 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: Contraindication towards long-term aspirin therapy; Terminal illness or cancer with life expectancy less than 2 years; Glomerular filtration rate (GFR) below 15 ml/min/1.73 m2; Modified rankin scale > 3 at time of enrollment; Planned combined cardiovascular interventional procedures at the time of enrollment.