Functional mitral regurgitation
Conditions
Interventions
Experimental group:Transcatheter mitral valve clips and steerable catheters +GDMT
Sponsors
Zhongshan Hospital Affiliated to Fudan University/Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Age =50 years old; 2. Moderate to severe functional mitral regurgitation caused by ring dilation; 3. High-risk patients undergoing traditional surgery 4. Still have symptoms of heart failure after one month of guidance-guided drug treatment or other device-assisted treatment; 5. The subject should take the medicine at the maximum tolerated dose one month before treatment; 6. If the following conditions are combined: atrial fibrillation, coronary artery disease, left ventricular dysfunction, and heart failure, the subject should have received GDMT and the patient should be stable; 7. Left ventricular ejection fraction (LVEF) measured by echocardiography was > 30%; 8. Left ventricular end-systolic diameter (LVESD) evaluated by echocardiography =70mm; 9. The research center evaluated the pulmonary artery systolic blood pressure (PASP) = 70mmHg according to ultrasound imaging, if PASP > 70 MMHG in ultrasound examination, PASP=70 mmHg was evaluated again through right cardiac catheterization; 10. Anatomic and otherwise assessed by the Center's cardiac team for the use of experimental instruments for repair; 11. The patient was able to understand and sign the informed consent and was willing to follow the protocol to complete the visit.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Etiology and history: 1. Moderate to severe right ventricular dysfunction; 2. invasive cardiomyopathy, hypertrophic cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of ischemic or non-ischemic etiology; 3. Previous history of rheumatic heart disease; 4. Patients who have undergone aortic valve interventional replacement (TAVR), percutaneous coronary intervention (PCI), surgical bypass (CABG), carotid intervention, or CRT, CRT-D, or implantable defibrillator within the past 30 days; Or known unstable angina or myocardial infarction within 30 days; Anatomical structure, hemodynamics 5. Contraindications of transfemoral intervention, atrial septal puncture, and cardiac superimposition; 6. Obvious mitral ring or mitral lobe calcification, mitral stenosis; 7. Left ventricular end-diastolic diameter (LVEDD) > 80mm; 8. Abnormal anatomical structure of the mitral valve, such as flail movement or perforation of the valve; 9. Patients with hemodynamic instability; 10. Echocardiography indicated intracardiac mass, thrombus or neoplasm; other 11. Previous or otherwise planned mitral ring repair and replacement (surgical or interventional) procedures; 12. Active systemic infections, including active endocarditis; 13. There is an untreatable allergic reaction or contraindication to any of the following: there is an allergy or contraindication to dual antiplatelet drugs, resulting in intolerance to intraoperative anticoagulation or postoperative antiplatelet therapy; Or Nitinol (nickel and titanium); Or contrast agent; Or other known surgical drug allergies or contraindications; 14. Heart surgery other than mitral valve intervention planned for any reason within the next 1 month; 15. Patients with TIA within 30 days, or prior stroke with permanent disability (mRS > 4); 16. Bleeding disorder or hypercoagulability; 17. Pregnant or lactating subjects; 18. Life expectancy of patients is less than 12 months; 19. Participated in any other clinical trial within 30 days prior to signing the informed consent and did not enter the group, or participated in any implant trial (other than a registered study) within the previous 30 days, or planned to participate in other clinical trials in the next 12 months; 20. Other conditions that the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There were no all-cause deaths and no heart failure readmissions one year after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate (trial group only);Device success rate (trial group only);Surgical success rate (trial group only);Patient success rate (trial group only);Ultrasonic result;NYHA graded improvement rate of cardiac function;Kansas City Cardiomyopathy Questionnaire Score (KCCQ);6-minute walking distance (6-MWD);Adverse Events (AE);Serious Adverse Events (SAE);Major Adverse Events (MAE);All-cause death;Cardiovascular related death;Heart failure readmission;Major cardiovascular Adverse Events (MACE);Mitral valve reintervention and reoperation rate; | — |
Countries
China
Contacts
Public ContactDaxin Zhou
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed