Mitral Valve
Conditions
Interventions
Experiment group:Transcatheter Mitral Valve Repair System
Sponsors
Yunan Fuwai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18; 2. Symptomatic functional MR (=3+) due to either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, MR severity based principally on the TTE study, confirmed by the Echocardiography Core Lab (ECL); 3. Left Ventricular Ejection Fraction (LVEF) is =20% and =50%; 4. Left ventricular end systolic diameter (LVESD) assessed by echocardiography = 70mm; 5. Those with MR = 3+and still have symptoms after GDMT (drug therapy guided by guidelines) determined by the heart team is stable; 6. Anatomically, it is suitable for mitral valve edge to edge repair and is evaluated to be suitable for the use of experimental medical devices; 7. It is evaluated that the femoral vein approach is appropriate and the atrial septal puncture is feasible; 8. NYHA New York Heart Function Rating = Grade II; 9. High BNP>150pg/mL or high NT pro BNP>600pg/mL in the past 12 months or hospitalization due to heart failure; 10. Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and are willing to accept relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous history of mitral valve surgery; 2. Effective opening area of mitral valve70mmHg); 6. Severe symptomatic carotid stenosis (ultrasonic examination showed that the stenosis degree was>70%); 7. End stage heart failure (ACC/AHA phase D); Or after heart transplantation; 8. Severe renal insufficiency (eGFR = 25mL/min) or chronic renal replacement therapy is required; 9. Diagnosis of invasive cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis or defect elimination Any structural heart other than blood or non ischemic dilated cardiomyopathy that causes heart failure venereal disease; 10. Myocardial infarction occurred within 4 weeks before enrollment; Or untreated patients with clinical significance who need blood circulation reconstruction Cured coronary artery disease; 11. Any cardiovascular intervention or carotid intervention or cardiac surgery within 30 days before enrollment Surgery or carotid surgery; Or implanted or renovated any rhythm manager within 30 days before enrollment Instruments (cardiac pacemaker [PPM], implantable cardioverter defibrillator [ICD], cardiac resynchronization therapy instrument [CRT], with or without implantable resynchronization therapy, cardioverter defibrillator [CRT-D]); 12. No cardiac resynchronization therapy device [CRT] was implanted due to Class I biventricular pacing indication; 13. Patients with stroke or transient ischemic attack within 30 days before enrollment; 14. Modified Rankin scale = 4 points; 15. Active endocarditis or active rheumatic heart disease; Or mitral valve changes caused by endocarditis and rheumatic heart disease; 16. Patients with active infection who are receiving antibiotic treatment (for temporary diseases, antibiotics should be stopped for at least 2 weeks before enrollment); 17. Patients with clear coagulation dysfunction and severe coagulation system diseases; Or patients with clear contraindications to anticoagulant and antiplatelet drugs; 18. Active peptic ulcer or gastrointestinal bleeding; 19. Life expectancy less than 12 months due to non heart disease; 20. Hemodynamic instability, defined as systolic blood pressure<90mmHg or cardiogenic shock when no afterload reducing drug is used; Or need positive muscle strength support; Or intra aortic balloon counterpulsation; Or other hemodynamic support devices are required; 21. Have a history of ipsilateral deep vein thrombosis (DVT) or DVT or pulmonary embolism (PE) 6 months before enrollment; 22. Severe chronic obstructive pulmonary disease (COPD) (requires continuous home oxygen therapy or long-term use of steroids); 23. Women of childbearing age who have positive pregnancy test or are in lactation or plan to become pregnant within the next 12 months; 24. Known allergy to contrast agents and nickel titanium memory alloy products; 25. There are contraindications to transesophageal echocardiography; Or general anesthesia contraindication exists; 26. Participated in clinical trials of other experimental biological agents or drugs or devices, and did not reach the primary end point at the time of enrollment; 27. The investigator determines that it is not suitable to par
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 month mortality;Hospitalization for heart failure 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate postoperative surgical success rate;Immediate postoperative device implantation success rate;Steerable tube passing performance (immediately after surgery);Incidence of postoperative hospitalization for heart failure (30 days postoperative, 6 months postoperative, 12 months postoperative);Proportion of participants with =2+ postoperative mitral regurgitation (30 days postoperative, 6 months postoperative, 12 postoperative). month);Proportion of participants with non-elective mitral valve re-intervention after surgery (6 months postoperative, 12 months postoperative);Proportion of subjects with NYHA New York cardiac function grade I or II after surgery (30 days after surgery, 6 months after surgery, 12 months after surgery, 2~5 years after surgery);Improvement in quality of life after surgery (30 days after surgery, 6 months after surgery, 12 months after surgery);The 6-minute walk test (6MWT) improved (30 days postoperatively, 6 months postoperatively, 12 postoperatively). month);Incidence of major adverse events (MAE) after surgery (30 days after surgery, 6 months after surgery, 12 months after surgery, 2~5 years after surgery);Postoperative all-cause mortality (30 days postoperative, 6 months postoperative, 12 months postoperative, 2~5 postoperative years);Postoperative incidence of cardiac death (30 days after surgery, 6 months after surgery, 12 months after surgery, 2~5 after surgery years);Incidence of serious adverse events after surgery (30 days after surgery, 6 months after surgery, 12 months after surgery, 2~5 after surgery years); | — |
Countries
china
Contacts
Public ContactXiangbin Pan
Yunan Fuwai Hospital
Outcome results
None listed