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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-23

Study Completion Date

2017-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

LAA Excision With AF Ablation Versus Oral Anticoagulants for Secondary Prevention of Stroke

NCT02478294

Atrial Fibrillation Stroke Systemic Embolism

COMPLETED

LAA Clipping Versus NOACs to Prevent Stroke in Non-paroxysmal Atrial Fibrillation.

NCT06021808

Non-paroxysmal Atrial Fibrillation

RECRUITING NA

Low-dose NOAC Versus GDMT After LAAO

NCT05960721

Atrial Fibrillation

RECRUITING NA

AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)

NCT04432220

Atrial Fibrillation Patients With Moderate or High Stroke Risk Who Had Undergone Catheter Ablation of Atrial Fibrillation

RECRUITING PHASE4

The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery.

NCT06172738

Left Atrial Appendage Thrombosis

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LAAO group

One-hundred consecutive patients who underwent left atrial appendage occlusion from October 2010 to March 2015 in 5 Korean tertiary cardiovascular centers will be retrospectively registered.

left atrial appendage occlusion

Intervention Type DEVICE

Percutaneous exclusion of left atrial appendage with Watchman or ACP devices

NOAC group

Two-hundred age-, sex-, CHA2DS2-VASc score- and HAS-BLED score- matched control will be selected with a 1:2 ratio among all patients treated with new oral anticoagulants to prevent ischemic events from 5 centers during same periods

New oral anticoagulants

Intervention Type DRUG

Include dabigatran, rivaroxaban, apixaban and edoxaban

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.