NCT03310801

Brief Summary

This study will retrospectively review and compare clinical outcomes between left atrial appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Status
completed

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

Study Start

First participant enrolled

August 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

September 17, 2017

Last Update Submit

October 10, 2017

Conditions

Atrial FibrillationCoronary Artery Disease

Keywords

left atrial appendage occlusionantithrombotic therapyatrial fibrillationpercutaneous coronary interventiondrug eluting stent

Outcome Measures

Primary Outcomes (1)

  • Composite of stroke and major bleeding

    Primary endpoint is a composite of stroke and major bleeding. Stroke is defined as ischemic cerebrovascular event included both transient ischemic attack and ischemic cerebral infarction. Major bleeding event was defined as moderate or severe bleeding according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria.

    From date of index procedure until the date of primary endpoint occur or date of last follow up, whichever came first, assessed up to 50 months

Study Arms (2)

LAAO with DAPT

patients with AF who underwent PCI and treated with LAAO(either ACP or Watchman) and DAPT

Procedure: ACP or Watchman

Conventional antithrombotic therapy

patients with AF who underwent PCI and treated with conventional antithrombotic therapy

Interventions

ACP or WatchmanPROCEDURE

Left atrial appnedage occlusion using ACP or Watchman

LAAO with DAPT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with AF who underwent PCI

You may qualify if:

  • patients with AF who underwent PCI and treated with LAAO and DAPT or conventional antithrombotic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial FibrillationCoronary Artery Disease

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Cheol Woong Yu, MD, PhD

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2017

First Posted

October 16, 2017

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 30, 2017

Last Updated

October 16, 2017

Record last verified: 2017-10