Severe Mitral Valve Regurgitation, Severe Mitral Valve Stenosis
Conditions
Brief summary
The study aims to evaluate the feasibility and safety of polymer artificial heart valve designed and developed by Shanghai HeartEpoch Medical technology Co. Ltd. for the treatment of the mitral valve diseases.
Interventions
DEVICEmitral valve replacement
device: polymer artificial heart valve mitral valve replacement
Sponsors
Shanghai HeartEpoch Medical Technology Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 60 years old; 2. severe mitral regurgitation or severe mitral stenosis confirmed by ECHO; 3. surgical mitral valve replacement;
Exclusion criteria
1. LVEF \< 50%; 2. History of cardiac surgery or history of cardiac intervention( within 1 year), Concurrent cardiac surgery(excluding tricuspid valve repair surgery or atrial fibrillation ablation) or cardiac interventional procedures; 3. STS ≥8； 4. intracardiac mass, thrombus or neoplasm confirmed by echo; 5. Coronary artery disease that requires revascularization； 6. A pacemaker need to be implanted; 7. Severe macrovascular lesions require surgical treatment; 8. Patients with active bleeding, bleeding tendencies or those who are unable to receive anticoagulant therapy； 9. There was evidence of acute myocardial infarction within 1 month before the surgery (Q-wave MI or non-Q-wave MI, CK-MB ≥ twice the normal level and/or elevated troponin)； 10. here was a history of cerebrovascular events (CVA) within 1 month before the surgery, including ischemic and hemorrhagic strokes, but excluding transient ischemic attacks (TIA); 11. Confirmed or suspected diagnosis of infective endocarditis or other active infections; 12. There are diseases that significantly affect the evaluation of treatment, such as patients with neurological disorders that affect cognitive abilities, and patients with malignant tumors and an expected lifespan of no more than one year； 13. Other situations in which patients are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite incidence rate of all-cause mortality and reoperation | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Implantation success rate | after the operation |
| The change of 6 minutes walk testing(6MWT) from baseline | 3months, 6months |
| Performance evaluation of implanted valves | 1 day after operation, 7 days after operation, 1 months after operation, 3 months after operation. |
| The change of NYHA from basement | 7 days after operation, 30 days after operation, 3 months after operation |
Countries
China
Contacts
CONTACTJian Gang Wang
Outcome results
None listed