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Research

Photo for LAAOS III

LAAOS III

Official Title

Left Atrial Appendage Occlusion Study III

Status

Ongoing

Overview

To determine if removing the left atrial appendage can reduce stroke and other complications on top of usual therapy.

Study Design

Randomized, blinded, international multicentre trial

Primary Endpoint

The primary outcome is the first occurrence of ischemic stroke* or transient ischemic attack with positive neuroimaging or systemic arterial embolism over the duration of follow-up. The secondary outcomes over the duration of follow-up (unless otherwise specified) are: 1) All cause stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism 2) Composite of ischemic stroke* or transient ischemic attack with positive neuroimaging or systemic arterial embolism or death 3) Ischemic stroke* or transient ischemic attack with positive neuroimaging or systemic arterial embolism occurring > 30 days after surgery 4) All cause death Safety Outcomes: 1) Hospitalization for heart failure 2) Operative safety outcomes a. Chest tube output in the first post-operative 24 hours b. Re-operation for bleeding within the first 48 hours post-surgery c. 30-day mortality 3) Major bleed 4) Myocardial infarction * Ischemic stroke is defined as any stroke that is not documented as primary hemorrhagic. † All components of composite outcomes will also be reported individually.

Number of Patients

4700

Number of Sites

100

Number of Countries

27

Study Period

2012–2021

Principal Investigator

Richard Whitlock, Stuart Connolly

Program Manager

Susan Chrolavicius, Shirley Pettit

Research Coordinator

Kate Brady