mitral regurgitation
Conditions
Interventions
Case series:Transapical implantation of MitraFix system
Sponsors
The Fuwai Yunnan Cardiovascular Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >18 years; 2. Severe symptomatic mitral regurgitation (MR grade 3-4+); 3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV; 4. Patient with high risk for Surgical Mitral Valve Replacement (SMVR; STS >=8% or if STS<8%, a documented heart team agreement that significant co-morbidities are not captured on STS) and agrees that the patient can undergo SMVR for bail-out / to address unfavorable circumstances if needed; 5. Essential Frailty Toolset score <=4; 6. Patient is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated; 7. Suitable for transapical procedure; 8. MitraFix System valve is compatible with the patient anatomy; 9. Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test); 10. Patient understands the nature of the procedure and provides written informed consent prior to any study specific assessments; 11. Patient is willing and able to comply with the specified study requirements and follow-up evaluations and can be contacted by telephone.
Exclusion criteria
Exclusion criteria: 1. Severe mitral stenosis; 2. Any prior or other planned mitral valve procedure; 3. Severe calcification of the mitral valve leaflets and mitral annulus (NOTE: calcified mitral annulus alone, without leaflet involvement, is not an exclusion criterion); 4. Mitral valve anatomy which may impede proper study device delivery or deployment; 5. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology; 6. Stroke or transient ischemic event within the previous 90 days; 7. Modified Rankin Scale >4 disability; 8. Acute myocardial infarction within the previous 90 days; 9. Hemodynamic instability: (systolic pressure <90 mmHg or requirement for inotropic support or mechanical hemodynamic support); 10. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within the previous 30 days; 11. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation; 12. Active endocarditis; 13. Active infections requiring current antibiotic therapy; 14. Known bleeding diathesis or hypercoagulable state; 15. Known active peptic ulcer or active gastrointestinal bleeding; 16. Subject is on chronic dialysis; 17. LVEF <30%; 18. Patients in whom transesophageal echocardiography is contraindicated or high risk; 19. Severe right ventricular dysfunction, defined per ASE guidelines; 20. Severe tricuspid or aortic valve disease, defined by ASE guidelines; 21. Need for emergent or urgent surgery for any reason; 22. Any percutaneous cardiovascular intervention, TAVR, cardiovascular surgery, or carotid surgery within the previous 60 days or is planned in the 12 months following the index procedure; 23. Allergy to nickel or titanium; 24. Life expectancy <1 year due to non-cardiac conditions; 25. Urgent organ allocation status for heart transplantation or prior orthotopic heart transplantation; 26. Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure success rate; | — |
Countries
China
Contacts
Public ContactXiangbin Pan
Fuwai Cardiovascular Hospital
Outcome results
None listed