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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Regional Hospital West Jutland
RECRUITING
Holstebro
Odense University Hospital
ACTIVE_NOT_RECRUITING
Odense
Finland
Helsinki University Central Hospital
RECRUITING
Helsinki
Oulu University Hospital
WITHDRAWN
Oulu
Turku University Hospital
NOT_YET_RECRUITING
Turku
Germany
Jena University Hospital
RECRUITING
Jena
Norway
Haukeland University Hospital
RECRUITING
Bergen
Oslo University Hospital
RECRUITING
Oslo
Trondheim University Hospital
NOT_YET_RECRUITING
Trondheim
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Skånes University Hospital
NOT_YET_RECRUITING
Lund
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Kasper Korsholm, MD
kasperkorsholm@clin.au.dk
004578452254
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2030-10-01
Participants
Target number of participants: 750
Treatments
Experimental: LAAO group
Patients will be treated with transcatheter left atrial appendage occlusion. The LAAO may be performed with the Amulet or Watchman device.
Experimental: NOAC group
Patients will be treated with one of the currently available NOAC drugs; Apixaban, Dabigatran, Edoxaban or Rivaroxaban.
Sponsors
Collaborators: Karolinska University Hospital, Lund University Hospital, Odense University Hospital, Helsinki University Central Hospital, Aarhus University Hospital, Jena University Hospital, Haukeland University Hospital, Trondheim University Hospital, Gødstrup Hospital, Oslo University Hospital, Aalborg University Hospital, Sahlgrenska University Hospital, Rigshospitalet, Denmark
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov