Explore the Efficacy and Safety of edoxabaN in Patients After Heart Valve Repair or Bioprosthetic vaLve Replacement (ENAVLE Trial)

Summary

1. objectives: The primary aim of ENAVLE is to explore the efficacy of edoxaban in patients with post mitral valve repair or bioprosthetic valve implantation 2. Primary / Secondary Endpoint 1\) Efficacy Endpoint Evaluation: Occurrence of thromboembolic events and any thrombus at repaired ring or bioprosthetic valves detected by follow up echocardiography or 3D CT scan 2\) Safety Endpoint Evaluation * Dysfunction of treated valve caused by thrombosis on echocardiography or 3D CT scan * Major or minor bleeding described in safety outcomes

Timeline

Start

2017-12-01

Primary completion

2019-09-30

Completion

2019-09-30

Drugs

Indications