NCT03108872

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 23, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

April 6, 2017

Last Update Submit

May 23, 2017

Conditions

Atrial Fibrillation

Keywords

AnticoagulantsAtrial AppendageStroke

Outcome Measures

Primary Outcomes (2)

  • Primary effectiveness endpoint

    The composite of cardiovascular or unexplained death, or ischemic stroke, or systemic embolism

    During 4 years

  • Primary safety endpoint

    Major bleeding or Serious device-related complications

    During 4 years

Secondary Outcomes (5)

  • Cardiovascular or unexplained death

    During 4 years

  • Ischemic stroke or systemic embolism

    During 4 years

  • Hemorrhagic stroke

    During 4 years

  • Major bleeding

    During 4 years

  • Serious device-related complications

    During 4 years

Study Arms (2)

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

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

Interventions

left atrial appendage occlusionDEVICE

Percutaneous exclusion of left atrial appendage with Watchman or ACP devices

LAAO group
New oral anticoagulantsDRUG

Include dabigatran, rivaroxaban, apixaban and edoxaban

NOAC group

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Atrial fibrillation with high risk of ischemic stroke or systemic embolism

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu

Bucheon-si, Gyeonggi-do, 422-711, South Korea

RECRUITING

Related Publications (1)

  • Kim JS, Lee H, Suh Y, Pak HN, Hong GR, Shim CY, Yu CW, Lee HJ, Kang WC, Shin ES, Choi RK, Kar S, Park JW, Lim DS, Jang Y. Left Atrial Appendage Occlusion in Non-Valvular Atrial Fibrillation in a Korean Multi-Center Registry. Circ J. 2016 Apr 25;80(5):1123-30. doi: 10.1253/circj.CJ-15-1134. Epub 2016 Mar 17.

    PMID: 26984716BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationStroke

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac CatheterizationCatheterizationTherapeuticsInvestigative Techniques

Central Study Contacts

Hyun Jong Lee, MD

CONTACT

82-10-6217-9315untouchables@sejongh.co.kr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 11, 2017

Study Start

May 23, 2017

Primary Completion

September 30, 2017

Study Completion

October 30, 2017

Last Updated

May 24, 2017

Record last verified: 2017-05

Locations

KR(1)