Organic mitral regurgitation
Conditions
Interventions
Experimental group:treated by transcatheter mitral valve clamp
Sponsors
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology/Xiamen University Affiliated Hospital of Cardiovascular Disease
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. NYHA cardiac function Grade II-IV; 3. Organic mitral regurgitation with symptoms of clinical heart failure confirmed by chest ultrasound as moderate to severe or severe (i.e. MR>=3+); 4. As judged by the cardiac team of the local clinical trial institution to be contraindicated or high-risk for surgical operations, the reference standard is recommended to meet one of the following three conditions; (1) STS score of surgical valve replacement >=8 or STS score of surgical valve repair >=6; (2) There are more than two frailty indexes; (3) There are more than two organ dysfunction; 5. It is anatomically suitable for transcatheter edge to edge mitral valve repair; 6. Femoral vein approach and atrial septal puncture are feasible; 7. Subject is willing to comply with protocol requirements and data collection procedures; Be able to understand the purpose of the trial and voluntarily participate and sign the informed consent by myself or legal guardian.
Exclusion criteria
Exclusion criteria: 1. Untreated severe coronary stenosis requiring revascularization or prior coronary intervention within 30 days; 2. More than moderate (grade >=3+) aortic stenosis or regurgitation, and other heart conditions requiring surgical treatment; 3. The anatomy of the valve lobe is not beneficial to the placement of the mitral valve clamp, including but not limited to severe mitral lobe and annulus calcification, insufficient mitral orifice area, previous history of mitral valve operation, rheumatic diseases of the mitral valve, etc.; 4. Intra-atrial thrombus, tumor, mass, etc.; 5. Left ventricular end-diastolic diameter (LVEDD) > 7.0 cm, left ventricular ejection fraction < 20%; 6. Patients with access obstacles such as inferior vena cava filter and tortuous obstruction of vena cava system; 7. There is contraindication of antithrombotic therapy; Or a history of cerebral hemorrhage, gastrointestinal hemorrhage, or hemorrhagic disease within 3 months; 8. Uncontrolled active infection, active stage of bacterial endocarditis; 9. Suffering from a disease that makes evaluation of treatment difficult (e.g. coma, cancer, mental illness, etc.); 10. Pregnant and lactating patients; 11. Other clinical trials in which the subjects participated have not reached the observed endpoint; 12. The investigator believed that the patient had poor compliance and could not complete the follow-up as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of 1 year after operation; | — |
Countries
China
Contacts
Public ContactDong Nian'guo/Wang Yan
Outcome results
None listed