NCT02478294

Brief Summary

This cohort study aims to evaluate thoracoscopic left atrial appendage excision plus atrial fibrillation ablation versus oral anticoagulants for the prevention of stroke and non-central nervous systemic embolism in patients with atrial fibrillation and thromboembolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
474

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

5.9 years

First QC Date

June 12, 2015

Last Update Submit

April 21, 2019

Conditions

Atrial FibrillationStrokeSystemic Embolism

Keywords

Atrial FibrillationStrokeSystemic embolismLeft atrial appendage excisionWarfarin

Outcome Measures

Primary Outcomes (1)

  • the composite of ischemic stroke/systemic embolism/transient ischemic attack (TIA), major bleeding, or all-cause mortality.

    at least 3 month follow-up

Secondary Outcomes (7)

  • ischemic strokes

    at least 3 month follow-up

  • all strokes (including ischemic and hemorrhagic)

    at least 3 month follow-up

  • Major and fatal bleeding events

    at least 3 month follow-up

  • Minor bleeding complication

    at least 3 month follow-up

  • all-cause mortality

    at least 3 month follow-up

  • +2 more secondary outcomes

Study Arms (2)

the surgical intervention group

Thoracoscopic LAA Excision plus AF Ablation. Patients receiving thoracoscopic left atrial appendage excision plus atrial fibrillation alation

Procedure: Thoracoscopic LAA Excision plus AF Ablation

oral anticoagulant treatment group

Warfarin or Novel Oral Anticoagulants. Patients receiving warfarin treatment (INR 2.0-3.0) or novel oral anticoagulants

Drug: Warfarin or Novel Oral Anticoagulants

Interventions

Thoracoscopic LAA Excision plus AF AblationPROCEDURE

In this group, patients receive thoracoscopic LAA excision plus AF ablation, which means thoracoscopic left atrial appendage excision plus atrial fibrillation ablation.

the surgical intervention group
Warfarin or Novel Oral AnticoagulantsDRUG

In this group, patients receive warfarin or novel oral anticoagulants

oral anticoagulant treatment group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with non-valvular AF and a previous history of embolic events are eligible for inclusion of this study.

You may qualify if:

  • years
  • Have documented AF episodes
  • The occurrence of ischemic stroke, TIA or systemic thromboembolism at least one month before enrollment
  • Capable of understanding and signing the CRF

You may not qualify if:

  • Reversible AF
  • Modified Rankin score ≥4
  • Having a history of rheumatic, severe valvular heart disease or heart valve replacement
  • Having symptomatic carotid artery disease
  • Having another disease which requires lifelong warfarin therapy
  • Medical conditions limiting expected survival to \<1 year
  • Women of childbearing potential (unless post-menopausal or surgically sterile)
  • Participation in any other clinical mortality trial
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 201129, China

Location

Biospecimen

Retention: NONE RETAINED

Serum and plasma

MeSH Terms

Conditions

Atrial FibrillationStroke

Interventions

Warfarin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of the Department of Cardiology

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 23, 2015

Study Start

January 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 23, 2019

Record last verified: 2019-04

Locations

CN(1)