Valvular heart disease
Conditions
Interventions
Sponsors
Department of Cardiology, West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old 2. NYHA class II, III, IVa cardiac function 3. Severe mitral regurgitation (3+ (moderate-severe)/4+ (severe)), and meet the following criteria: effective regurgitation orifice area (EROA) >= 20mm2 or regurgitation volume >= 40ml. 4. Subjects receiving optimal guideline-directed drug therapy strategies for heart failure, or for at least 30 days after implantation of CRT 5. The cardiac team (including at least cardiac surgeons, cardiologists, and imaging specialists) considered the subject's mitral valve to be routinely surgically opened based on surgical risk scores, frailty, or comorbidities (MVARC Part 1 recommendations, see appendix). Elevated risk of revision or replacement surgery and confirmed by a patient screening committee 6. Able to undergo transesophageal echocardiography (TEE) and/or transcatheter intracardiac echocardiography (ICE) 7. Subjects understand the research requirements and treatment procedures, and provide written informed consent 8. Subjects receive KCCQ scores and are willing to return to the corresponding center (hospital) for follow-up as planned after surgery 9. Suitable for transfemoral and transseptal procedures 10. Native mitral valve geometry and size, and left ventricular outflow tract (LVOT) characteristics matched to the Cardiovalve system (as assessed by the patient screening committee) 11. The height of the foramen ovale puncture point from the mitral valve plane> 35mm (CT) 12. The distance between the anterior and posterior commissures of the mitral valve is suitable for the size range of the valve (CT) 13. Right femoral vein diameter > 9mm (CT) 14. Calculate the minimum LVOT cross-sectional area after device implantation >= 30%
Exclusion criteria
Exclusion criteria: 1. Stroke or TIA within 3 months before surgery, or modified Rankin score >= 4 (disabling stroke) 2. Acute myocardial infarction within 30 days before surgery 3. Any previous heart valve surgery or transcatheter mitral valve surgery 4. Any percutaneous cardiovascular intervention, or cardiovascular surgery, or carotid artery surgery within 30 days prior to surgery 5. Rheumatic heart disease or infective endocarditis within 3 months before surgery 6. Other heart diseases causing heart failure other than ischemic or non-ischemic dilated cardiomyopathy, including hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, combined with contracture of chordae tendineae, congenital malformations and Severe organ damage with lack of valve tissue, or any other structural heart disease, etc. 7. Inferior vena cava filter implantation status or atrial septal device implantation status (restricted femoral vein access and interatrial access) 8. Untreated severe coronary heart disease requiring revascularization 9. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation 10. Aortic or pulmonary valve disease requiring surgery 11. CRT/ICD implantation within 30 days before surgery 12. Patients with NYHA cardiac function class IVb 13. Patient awaiting heart transplant or previous history of orthotopic heart transplant 14. Patient with severe symptomatic carotid stenosis 15. Left ventricular ejection fraction (LVEF) 70mm 17. Significant abnormality of mitral valve or subvalvular device 18. Severe mitral annular or leaflet calcification 19. Left atrial or left ventricular hematoma, vegetation or mass 20. Severe right ventricular dysfunction 21. Severe tricuspid or aortic valve disease 22. Subjects are currently participating in other clinical studies 23. Subject is allergic to bovine tissue 24. Subject with uncontrolled hypotension 25. Hemodynamic instability, defined as systemic systolic blood pressure 70mmHg 30. The patient's renal function is complete (creatinine>2.5mg/dl) 31. Emergency or emergency surgery or any planned cardiac surgery for any reason within 12 days of the trial surgery 32. Subject with hepatic insufficiency 33. Subject has comorbidities leading to life expectancy < 1 year 34. Active infection requiring antibiotic treatment 35. Female subjects who are pregnant, breastfeeding, or plan to become pregnant within 1 year, and who have not used effective contraception during their childbearing years. 36. Chronic anemia (hemoglobin Hgb <90g/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of immediate surgery; | — |
Countries
China
Contacts
Public ContactMao Chen
Outcome results
None listed