moderate to severe and severe mitral regurgitation
Conditions
Interventions
Experiment group:treated by transcatheter mitral valve clamp
Sponsors
Union hosptial Tongji Medical College Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old; 2. Patients with clinical symptoms of heart failure and confirmed by transthoracic ultrasonography as moderate to severe or severe mitral regurgitation (ie, MR>=3+ grade), and the disease type and condition conform to one of the following; (1) Degenerative mitral regurgitation: at least two cardiac surgeons judge that surgery is contraindicated or high-risk, and at least one of the following three conditions is met; 1) STS score >= 8 points for valve replacement or STS score = 6 points for valve repair; 2) There are more than 2 frailty indices; 3) There are two or more organ insufficiency; (2) Functional mitral regurgitation: patients with NYHA cardiac function class 2-4 after reasonable device therapy and standardized drug therapy according to the guidelines or patients with heart failure without significant improvement in echocardiographic parameters, and combined with Functional moderate-to-severe or severe mitral regurgitation; 3. Anatomically suitable for transcatheter mitral valve edge-to-edge repair; 4. Femoral vein access and atrial septal puncture are feasible; 5. The subjects are willing and abide by the protocol requirements and data collection procedures; they can understand the purpose of the trial, and they or their legal guardians voluntarily participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Untreated severe coronary stenosis requires revascularization, or coronary intervention within 30 days; 2. Combined with moderate or higher (>=3+ grade) aortic valve stenosis or regurgitation, and other heart diseases requiring surgical treatment; 3. The valve leaflet anatomy is not conducive to the placement of the mitral valve clip, including but not limited to severe mitral valve and valve annulus calcification, insufficient mitral valve orifice area, previous history of mitral valve surgery, mitral valve rheumatic disease Wait; 4. Atrial thrombus, vegetations, masses, etc.; 5. Left ventricular end-diastolic diameter (LVEDD) > 8.0 cm, left ventricular ejection fraction < 20%; 6. Patients with access obstacles such as inferior vena cava filter and tortuous obstruction of the vena cava system; 7. There is a contraindication to antithrombotic therapy; or a history of cerebral hemorrhage, gastrointestinal hemorrhage, or hemorrhagic disease within 3 months; 8. Uncontrolled active infection, active bacterial endocarditis; 9. Suffering from a disease that will make it difficult to evaluate treatment (such as coma, cancer, mental illness, etc.); 10. Other clinical trials the subjects participated in have not yet reached the observation end point; 11. The investigator believes that the patient has poor compliance and cannot complete the follow-up as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| immediate procedural success rate;The occurrence of major adverse events ; | — |
Countries
China
Contacts
Public ContactDong Nianguo
Union hosptial Tongji Medical College Huazhong University of Science and Technology
Outcome results
None listed