RecruitingNot ApplicableNCT03642509

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)


Sponsor

University of Aarhus

Enrollment

750 participants

Start Date

Jan 1, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two ways to prevent strokes in people who have an irregular heartbeat called atrial fibrillation: taking blood thinning pills long-term versus having a small procedure to close off a part of the heart (called the left atrial appendage) where dangerous blood clots can form. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with atrial fibrillation (an irregular heartbeat) - You qualify for long-term blood thinning medication - You had a stroke within the past 6 months, or a mini-stroke (TIA) within the past 6 months confirmed by a brain scan **You may NOT be eligible if...** - You have significant disability from a prior stroke (difficulty with everyday activities) - Your kidneys are functioning very poorly - You cannot take aspirin long-term - You have another heart procedure planned at the same time - You have a terminal illness or cancer with a life expectancy of less than 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELeft atrial appendage occlusion

Interventional left atrial appendage occlusion with the Amulet or Watchman device

DRUGNOAC

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

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NCT03642509


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