Status:

COMPLETED

Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

Lead Sponsor:

Samsung Medical Center

Conditions:

Atrial Fibrillation

Anticoagulants and Bleeding Disorders

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

The aim of this study is to compare the safety and efficacy of edoxaban and warfarin for prevention of stroke during a 6-month follow up after total thoracoscopic ablation.

Detailed Description

In Korea, 5% of patients older than 65 years and 10% of patients older than 80 have a history of atrial fibrillation (AF), which is often associated with sudden death and stroke. Medication and percut...

Eligibility Criteria

Inclusion

  • Patients aged 18 years or older (not exceed 80 years old).
  • Elective thoracoscopic ablation.
  • Presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent).

Exclusion

  • Chronic obstructive pulmonary disease (COPD).
  • History of pulmonary tuberculosis.
  • Other cardiac comorbidities including valvular disease, coronary artery disease.
  • Congenital heart anomalies except for atrial septal defect.
  • Known, clinically important anemia or thrombocytopenia.
  • Pregnancy or lactation.
  • Malignancy.
  • Intracardiac mass or thrombus
  • Life expectancy less than 1 year.

Key Trial Info

Start Date :

December 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 10 2020

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04121767

Start Date

December 1 2017

End Date

July 10 2020

Last Update

August 3 2020

Active Locations (1)

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Samsung Medical Center

Seoul, South Korea, 135-710