NCT03108872

Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation

Long Term Clinical Outcomes of Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation; From Korean Multicenter Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Sejong General Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

We will compare long-term effectiveness and safety in patients with atrial fibrillation treated with left atrial appendage occlusion versus new oral anticoagulants to prevent ischemic stroke from multicenter registry data

Detailed description

Atrial fibrillation (AF) is associated with a substantial risk of stroke and systemic embolism. Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation and high risk of ischemic stroke. However, their use is limited by a narrow therapeutic range, increased risk of intracranial hemorrhage, the need for continuous monitoring of INR, and drug or food interaction. New oral anticoagulants (NOACs), the direct thrombin inhibitor and the factor Xa inhibitor, have settled these limitations of warfarin therapy. In four pivotal phase 3 clinical trials and their meta-analysis, NOACs have been shown to significantly reduce ischemic stroke, intracranial hemorrhage, and mortality, and had similar major bleeding as for warfarin in patients with non-valvular atrial fibrillation (NVAF). Another new treatment strategy for prevention of stroke is left atrial appendage occlusion (LAAO). Left atrial appendage has been considered to be an origin of thrombi more than 90% of cases. The concept that exclusion of LAA from the circulation reduces the risk of stroke in patients with NVAF is therefore being tested in clinical studies. LAAO with Watchman device and only aspirin were proved to be non-inferior to warfarin for ischemic stroke prevention or systemic embolism. And, LAAO reduced significantly cardiac death and hemorrhagic stroke compared to warfarin in a long-term follow up. Up to date, there was no study to compare long-term clinical outcomes between LAAO and NOACs, which are two new treatment strategies for stroke prevention in patients with NVAF.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	left atrial appendage occlusion	Percutaneous exclusion of left atrial appendage with Watchman or ACP devices
DRUG	New oral anticoagulants	Include dabigatran, rivaroxaban, apixaban and edoxaban

Timeline

• Start date: 2017-05-23
• Primary completion: 2017-09-30
• Completion: 2017-10-30
• First posted: 2017-04-11
• Last updated: 2017-05-24

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study