Mitral valve disease
Conditions
Interventions
Experimental group:HighlifeTM transcatheter mitral valve replacement
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged > 18 years; 2.The patient's condition assessed by multidisciplinary cardiac team needs mitral valve surgery intervention to improve; 3.The multidisciplinary cardiac team assessed that the patients were at high risk of surgical intervention and were not suitable for routine surgical intervention; 4.Patients' New York heart function classification (NYHA) is >= grade II; 5.The anatomical structure of the patient is suitable to use highLife TM transcatheter mitral valve replacement system; 6.Voluntarily participate in and sign the informed consent form, and be able to cooperate with patients who have completed the whole trial process; 7.Patients who can perform TEE; 8.Patients who followed the follow-up plan and completed the examination; 9.Patients who can be treated with anticoagulants or antiplatelet drugs.
Exclusion criteria
Exclusion criteria: 1.Patients with any stroke /TIA within 30 days; 2.Severe symptomatic carotid artery stenosis (stenosis by noninvasive imaging > 70%); 3.Active infection requiring antibiotic treatment: 4.Active ulcer or gastrointestinal bleeding in the past 3 months; 5.Easy bleeding constitution, history of coagulation dysfunction or refusal of future blood transfusion treatment; 6.Pregnant or lactating patients, or patients who plan to be pregnant within 12 months: 7.Patients enrolled in another clinical study and in the follow-up period: 8.Patients who are known to be allergic to equipment parts or contrast agents; 9.Patients with life expectancy less than 12 months due to non-cardiac diseases: 10.Patients who need emergency surgery for any reason or who plan to undergo heart surgery within 12 months; 11.Inappropriate size of mitral valve annulus or leaflet ( 45mm); 12.Acute myocardial infarction (Q-wave myocardial infarction or non-Q-wave myocardial infarction, accompanied by CK-MB more than twice the normal value and/or increased Tn) occurred in the past month. 13.Untreated coronary artery lesions with obvious symptoms requiring revascularization; 14.Untreated severe aortic stenosis and severe aortic regurgitation; 15.There are mechanical aortic valves; 16.Severe lesions of tricuspid valve requiring surgical intervention; 17.Obvious right ventricular dysfunction (such as edema of both lower limbs with increased carotid pulsation and hepatomegaly); 18.LVEF 70mmHg); 23.New hypotension (systolic blood pressure < 90mmHg) or mechanical hemodynamic support.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of immediate surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of cardiac function;Postoperative quality of life of subjects;Evaluation of artificial valve function; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed