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NCT03642509Recruiting

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)

Source: ClinicalTrials.gov · Last updated 21 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
750 (estimated)
First submitted
6 Jul 2018
Start date
Jan 2019
Primary completion date
Jan 2026
Lead sponsor
University of Aarhus
NCT number
NCT03642509

What you commit to

  • Study type: Interventional
  • Planned participants: 750
  • From Jan 2019 to the primary completion date, Jan 2026
  • 15 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication towards long-term aspirin therapy

Other illness

  • Terminal illness or cancer with life expectancy less than 2 years.

Lab values

  • Glomerular filtration rate (GFR) below 15 ml/min/1.73 m2

Other

  • Modified rankin scale \> 3 at time of enrollment
  • Planned combined cardiovascular interventional procedures at the time of enrollment

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Jena University Hospital
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JenaGermanyRecruiting
Aalborg University Hospital
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AalborgDenmarkRecruiting
Aarhus University Hospital
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AarhusDenmarkRecruiting
Rigshospitalet
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CopenhagenDenmarkNot yet recruiting
Regional Hospital West Jutland
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HolstebroDenmarkRecruiting
Odense University Hospital
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OdenseDenmarkActive, not recruiting
Helsinki University Central Hospital
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HelsinkiFinlandRecruiting
Oulu University Hospital
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OuluFinlandWithdrawn
Turku University Hospital
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TurkuFinlandNot yet recruiting
Haukeland University Hospital
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BergenNorwayRecruiting
Oslo University Hospital
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OsloNorwayRecruiting
Trondheim University Hospital
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TrondheimNorwayNot yet recruiting
Sahlgrenska University Hospital
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GothenburgSwedenRecruiting
Skånes University Hospital
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LundSwedenNot yet recruiting
Karolinska University Hospital
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StockholmSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.