Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation (Occlusion-AF)

University of Aarhus

Status: Enrolling

Conditions: Atrial Fibrillation; Stroke

Treatments: Drug: NOAC; Device: Left atrial appendage occlusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03642509

Occlusion-AF-AUH250418-32

Details and patient eligibility

About

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).

Full description

An investigator-initiated multicenter, randomized open-label non-inferiority trial with blinded outcome evaluation (PROBE design). The active comparison LAAO is tested against NOAC therapy in a 1:1 stratified randomization. Patients should have AF, and an ischemic stroke or TIA within 6 months prior to enrollment. In total 750 patients will be included. Follow-up will be based on in-office and telephone follow-up during the first 3 years after randomization, along with up to 10 years long-term follow-up through the National Patient Registries.

The main study outcomes: The primary outcome is a composite of stroke (hemorrhagic or ischemic), systemic embolism, major bleeding or all-cause mortality assessed after at least two years follow-up for the last enrolled patient. Secondary outcomes will examine early and late safety outcome measures. The long-term outcome will be assessed up to 10-years after randomization through the National Patient Registries.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 2 patient groups

LAAO group

Experimental group

Description:

Patients will be treated with transcatheter left atrial appendage occlusion. The LAAO may be performed with the Amulet or Watchman device.

Treatment:

Device: Left atrial appendage occlusion

NOAC group

Experimental group

Description:

Patients will be treated with one of the currently available NOAC drugs; Apixaban, Dabigatran, Edoxaban or Rivaroxaban.

Treatment:

Drug: NOAC