safety and efficacy of the highlife transcatherter mitral valve replacement system in patients with moderate-severe or severe mitral regurgitation in china

Conditions: Mitral Regurgitation

Summary: to observe and evaluate the safety and efficacy of the highlife transcatheter mitral valve replacement system in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.


Eligibility criteria:
inclusion criteria: 1. patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process; 2. age ≥ 18 years old; 3. moderate-severe or severe mitral regurgitation (≥3+); note 1: patients with ischemic or non-ischemic heart disease induced symptomatic secondary mitral regurgitation as the primary cause must be treated for at least 1 month after optimal guideline medical therapy (gdmt). echocardiography should be performed 3 months after cardiac resynchronization therapy and 1 month after coronary revascularization to assess the degree of regurgitation. note 2: for patients with primary mitral regurgitation, the multidisciplinary cardiac team of the research center needs to use a standard scoring system, considering multiple factors such as complications, frailty, and disability, ensuring the enrolled with a high risk of surgery. 4. patients with new york heart association (nyha) functional ratings are class ii, iii, or ambulatory class iv; 5. anatomically appropriate for treatment with the highlife transcatheter mitral valve replacement system. exclusion criteria: 1. patients had any stroke/tia within 30 days; 2. patients with severe symptomatic bilateral carotid stenosis (\>70% stenosis on non-invasive imaging); 3. patients with active infection requiring antibiotic therapy; 4. patients with active ulcer or gastrointestinal bleeding within the past 3 months; 5. patients with history of coagulopathy or refuse future blood transfusion; 6. patients unable to undergo transesophageal echocardiography (tee); 7. patients who are pregnant or breastfeeding, or planning to have children within 12 months; 8. patients who are unable to adhere to the follow-up schedule and complete the examination; 9. patients enrolled in other clinical studies and within the follow-up period; 10. patients with known allergies to device components or contrast agents; 11. patients unable to receive anticoagulant or antiplatelet therapy; 12. patients with a life expectancy of less than 12 months due to non-cardiac disease; 13. patients requiring emergency surgical treatment; 14. patients scheduled for cardiac surgery within 12 months; 15. patients with an inappropriate mitral annulus or leaflet size (\ 45 mm); 16. patients with moderate or above mitral stenosis; 17. flail mitral leaflets, or moderate to severe mitral valve prolapse; 18. patients with severe hepatic or renal insufficiency; 19. patients with severe calcification of the mitral annulus and/or mitral leaflets; 20. patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device; 21. patients had acute myocardial infarction (mi) (q-wave mi, or non-q-wave mi, with ck-mb twice the normal and/or t-mb) within the past 1 month; 22. patients with untreated symptomatic coronary lesions requiring revascularization; 23. patients with untreated severe aortic stenosis and severe aortic regurgitation; 24. patients with aortic valve prosthesis; 25. patients with severe tricuspid valve lesions requiring surgical intervention; 26. patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly; 27. lvef \ 70 mm; 28. patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm; 29. hypertrophic obstructive cardiomyopathy (hocm); 30. patients with active or recent (within 3 months) endocarditis; 31. patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (spap) \> 70 mmhg) 32. patients with hypotension (systolic blood pressure \<90 mmhg) occurring within 7 days or mechanical hemodynamic support.