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

• Status: Recruiting
• Trial end date: 2030-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Aalborg Universitetshospital; Aalborg University Hospital; Aarhus University Hospital; Haukeland University Hospital; Helsinki University Central Hospital; Karolinska University Hospital; Odense University Hospital; Sahlgrenska University Hospital, Sweden; Turku University Hospital
• Treatments: Apixaban; Dabigatran; Edoxaban; Rivaroxaban

Criteria

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.