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

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).

Conditions

• Atrial Fibrillation
• Stroke

Interventions

DEVICE

Left atrial appendage occlusion

Interventional left atrial appendage occlusion with the Amulet or Watchman device

DRUG

NOAC

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.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Gødstrup Hospital

  collaborator OTHER

• Lund University Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Trondheim University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Jena University Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Kasper Korsholm, MD · Aarhus University Hospital

• Jens Erik Nielsen-Kudsk, MD DMSc Prof · Aarhus University Hospital

• Dorte Damgaard, MD PhD · Aarhus University Hospital

• Søren Paaske Johnsen, MD PhD Prof · Aalborg University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2026-01-01

Completion

2030-10-01

Countries

• Denmark
• Finland
• Germany
• Norway
• Sweden

Study Locations