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

May 23, 2017 updated by: Hyun Jong Lee, Sejong General Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Bucheon, Gyeonggi, Korea, Republic of, 422-711
        • Recruiting
        • Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Atrial fibrillation with high risk of ischemic stroke or systemic embolism

Description

Inclusion Criteria:

  1. Patients with atrial fibrillation, who LAAO or NOAC to prevent ischemic stroke or systemic embolism
  2. Patients with CHA2DS2-VASc score >1

Exclusion Criteria:

  1. Patients who failed to successfully implant LAAO
  2. Patients who receive new oral anticoagulant less than 6 months without clinical events
  3. Patients with mitral stenosis more than mild grade
  4. Patients with prosthetic heart valve

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: left atrial appendage occlusion
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
Drug: New oral anticoagulants
Include dabigatran, rivaroxaban, apixaban and edoxaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary effectiveness endpoint
Time Frame: During 4 years
The composite of cardiovascular or unexplained death, or ischemic stroke, or systemic embolism
During 4 years
Primary safety endpoint
Time Frame: During 4 years
Major bleeding or Serious device-related complications
During 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular or unexplained death
Time Frame: During 4 years
During 4 years
Ischemic stroke or systemic embolism
Time Frame: During 4 years
During 4 years
Hemorrhagic stroke
Time Frame: During 4 years
During 4 years
Major bleeding
Time Frame: During 4 years
Bleeding event that required at least 2 units of packed RBCs or Symptomatic bleeding in a critical area or organ.
During 4 years
Serious device-related complications
Time Frame: During 4 years
Serious pericardial effusion need procedure or surgery, peri-procedural stroke, or device embolization
During 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sejong General Hospital

Collaborators

Ulsan University Hospital
Korea University Anam Hospital
Yonsei University
Gachon University Gil Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 23, 2017

Primary Completion (ANTICIPATED)

September 30, 2017

Study Completion (ANTICIPATED)

October 30, 2017

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (ACTUAL)

April 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ver 1.0_20170306

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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