Mitral Valve Disease
Conditions
Interventions
MITRIS RESILIA Group:none
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: The participants must meet all of the following conditions to be included in the study: 1. Age >= 50 years; 2. After preoperative assessment, the participants need to undergo elective mitral valve replacement* (using autologous valve or an implanted artificial valve), which may or may not be combined with concurrent coronary artery bypass grafting (CABG), tricuspid valve repair, surgical ablation of atrial fibrillation, or surgical closure of the left atrial appendage; 3.The patient or their authorized family member requests the implantation of the MITRIS RESILIA valve; 4.The participants plan to complete a maximum of 5 years of follow-up at the research center; 5.The participants have signed a written informed consent form before the surgery. * Note: The surgical methods can include median sternotomy, minimally invasive small incision, laparoscopic assistance, and robotic assistance
Exclusion criteria
Exclusion criteria: If the subjects meet any of the following conditions, they will be excluded: 1.Those with active endocarditis/myocarditis, or who have had endocarditis/myocarditis within 3 months prior to the planned mitral valve replacement surgery; 2.Subjects requiring emergency surgery; 3.Subjects requiring multi-valve surgery (except for mitral valve replacement combined with tricuspid valve repair); 4.Patients with a previous history of mitral valve replacement/repair or tricuspid valve replacement surgery; 5.Subjects requiring aortic root replacement surgery; 6.Those with hypertrophic obstructive cardiomyopathy; 7.Subjects with an expected lifespan of <= 12 months due to any reason; 8.Subjects with contraindications to surgical procedures or general anesthesia; 9.Subjects currently participating in other clinical trials that may interfere with the assessment of the endpoints of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality;Incidence of Structural Valve Deterioration (SVD) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality rates;Bioprosthetic Valve Dysfunction,BVD;Clinical complications (such as bleeding, stroke, and readmission);Valvular hemodynamic performance (assessed through echocardiography); New York Heart Association,NYHA; Kansas City Cardiomyopathy Questionnaire,KCCQ; | — |
Countries
China
Contacts
Public ContactJianggang Wang
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed