Moderate or severe degenerative mitral regurgitation (DMR)
Conditions
Interventions
Experimental group:Implantation of experimental medical device
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age =18 years, gender is not limited; 2) NYHA cardiac function class II-IV; 3) Moderate-severe or severe degenerative mitral regurgitation (degree of regurgitation MR =3+) confirmed by TEE or TTE; 4) Clinical symptoms, or no clinical symptoms but LVEF = 60% or LVESD = 40 mm; 5) Patients diagnosed by a cardiologist as being at high risk for mitral valve surgery, the reference standard suggests that one of the following four conditions be met: a. American Association for Thoracic Surgery Adult Cardiac Surgery Risk Scoring System (STS score) STS score for valve repair = 6 or STS score for valve replacement = 8 (high risk); b.Presence of 2 or more frailty indices (moderate to severe frailty); c. Presence of 2 or more major organ insufficiencies that do not improve postoperatively; d. Comprehensive assessment by the cardiac team of the patient's comorbidities with other diseases or factors that make the patient unsuitable for surgery; 6) anatomically suitable for transcatheter mitral valve repair and eligible for femoral vein access and septal puncture; (7) Voluntary participation and signing of informed consent, willingness to accept relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1) Patients who are intolerant to treatment, including allergy or hypersensitivity to anticoagulant therapy or antiplatelet therapy; 2) Patients with thrombus in the inferior vena cava or femoral vein, or with access obstacles such as inferior vena cava filters or tortuous obstruction of the vena cava system; 3) Patients with known allergies or contrast sensitivities to nickel/titanium, cobalt, chromium, polyesters, fluorinated polymers, etc; 4) Patients with active mitral valve endocarditis, or rheumatic mitral valve lesions , or mitral valve leaflet changes (e.g., poor compliance, perforation, etc.) due to endocarditis or rheumatic heart valve disease; 5) Uncontrolled active infection; 6) Patients with cardiac ultrasound showing intracardiac thrombi, redundant organisms, and masses; 7) Untreated severe coronary artery stenosis requiring haemodialysis or previously treated with coronary artery surgery within 30 days; 8) Aortic stenosis or regurgitation that, in the judgement of the clinician, requires surgical intervention, and other cardiac conditions requiring surgical intervention; 9) Leaflet anatomy unfavourable for mitral clip placement, including but not limited to: mitral orifice area 70 mmHg measured by ultrasound or right heart catheterisation, if simultaneous measurements are taken, the right heart catheterisation measurement shall prevail); 12) Patients with echocardiographic evidence of moderately severe or severe right heart dysfunction; 13) Contraindication to antithrombotic therapy; or history of cerebral haemorrhage, gastrointestinal bleeding, or bleeding disorders within 3 months; 14) Patients who are unable to participate in the 6-minute walk test; 15) Presence of illnesses that would make treatment evaluation difficult (e.g., coma, cancer, mental illness, etc.); 16) Pregnant and breastfeeding women who plan to become pregnant in the next 12 months; 17) Life expectancy <1 year, as judged by the clinician; 18) Is participating in an interventional clinical study of another device or drug (except where the investigator believes it will not affect the primary evaluation metrics); 19) Any other condition that the investigator considers inappropriate for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Product Effectiveness Rate 12 Months After Surgery;Incidence of major adverse events within 1 month postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate of postoperative products;Incidence of major adverse events;Rate of NYHA cardiac class I or II after surgery;Incidence of heart failure re-hospitalisation;Quality of life assessment;Change from baseline in 6-minute walking distance;Change from baseline in left ventricular function;Change from Baseline in Extent of Mitral Regurgitation; | — |
Countries
China
Contacts
Public ContactPan Xiangbin
Fuwai Hospital, Chinese Academy of Medical Sciences, Shenzhen Hospital
Outcome results
None listed