MV(Mitral Valve) Repair Clinical Trial
Official title:
Explore the Efficacy and Safety of edoxabaN in Patients After Heart Valve Repair or Bioprosthetic vaLve Replacement (ENAVLE Trial)
Verified date | October 2019 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 220 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Patients aged 20-85 years with - MV repair or Bioprosthetic MV or AV replacement - Patients with written informed consent Exclusion Criteria: - Previous mechanical prosthetic heart valve replacement - Patients who underwent TAVI - Concomitant bioprosthetic valve replacement of mechanical tricuspid or pulmonary replacement at the time of the index valve replacement surgery - Clinically relevant paravalvular leaks - Previous history of endocarditis - Complex congenital heart abnormality - Acute coronary syndrome within one month - Uncontrolled hypertension - Previous history of hemorrhagic stroke - At high risk for bleeding - Active hepatitis or liver dysfunction (AST/ALT> 3times of upper normal limits) - Creatinine clearance < 30ml/min - Patients with a clear indication for long-term dual antiplatelet therapy - Malignancy or radiation therapy within one month - Treatment with selected drugs that my interact with edoxaban (specific P-gp inhibitors, ie. verapamil, quinidine; the short-term use of azithromycin, clarithromycin, erythromycin, oral itraconazole, oral ketoconazole) - At of pregnancy or breastfeeding - Known allergy to warfarin or edoxaban |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of thromboembolic event | Occurrence of thromboembolic events and any thrombus at repaired ring or bioprosthetic valves detected by follow up echocardiography or 3D CT scan | 12 weeks | |
Secondary | Dysfunction of treated valve | Dysfunction of treated valve caused by thrombosis on echocardiography or 3D CT scan | 12 weeks |