Munich Transcatheter Mitral Valve Safety and Effectiveness

The Munich Trascatheter Mitral Valve System is intended for beating heart, mitral valve replacement in patients with a diseased, damaged, or malfunctioning mitral valve. Access is provided through the Femoral Vein and transseptal approach by means of a 27Fr catheter.

The bioprosthetic valve consists of a self-expanding, tri-leaflet, dry bovine-pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The valve is available in three sizes and has been designed to reduce the complexity of implantation in comparison to other TMVR systems.

This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the Munich TMVR System in a population of patients with moderate to severe, symptomatic mitral regurgitation, who are not suitable for surgical treatments.

Patients who meet all of the study inclusion criteria, will be treated with the Munich valve. After the intervention, patients will be followed up closely for 12 months. Long term safety and efficacy data will be collected annually up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Moderate or severe mitral regurgitation (\> 3+)

   1. For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml
   2. For Secondary MR: EROA \> 30 mm2 or regurgitant volume \> 45ml (i.e., MR moderate or severe by ASE criteria)
3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
4. Subject is under guideline directed medical therapy for at least one month
5. Subject is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty and disability
6. Subject meets the anatomical criteria for Munich TMVR System
7. Patient is willing to participate in the study and provides signed informed consent.

Exclusion Criteria:

General Conditions

1. Subject who is currently participating in an investigational study, other than this study
2. Subjects allergic to bovine tissue
3. Subjects with uncontrolled hypotension
4. Hemodynamic instability
5. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated and has an allergy to Nitinol alloys
6. Intolerance to antiplatelet, anticoagulant or thrombolytic medications
7. Bleeding diathesis or hypercoagulable state
8. Active peptic ulcer or active gastrointestinal bleeding
9. Pulmonary artery systolic pressure \>70 mmHg
10. Renal insufficiency
11. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
12. Subject with hepatic insufficiency
13. Subject has a co-morbid illness that may result in a life expectancy of less than one year
14. Active infection that requires antibiotic therapy
15. Subject is pregnant, breastfeeding or intend to become pregnant within one year, and female subjects in childbearing age NOT using a highly effective method of contraception with a failure rate of less than 1% per year.

    Comorbidities
16. Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
17. Acute myocardial infarction within the previous 30 day
18. Any prior heart valve surgery or transcatheter mitral intervention
19. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
20. Rheumatic heart disease or endocarditis within the previous 3 months
21. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis
22. Severe organic lesion with retracted chordae or congenital malformation and lack of valvular tissue
23. Any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
24. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
25. Untreated clinically significant coronary artery disease requiring revascularization
26. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
27. Aortic or pulmonic valve disease requiring surgery
28. CRT/ICD implant within 30 days
29. NYHA class IVb
30. UNOS stadium 1 heart transplantation or previous orthotopic heart transplantation

    Anatomical and Functional
31. Left Ventricular Ejection Fraction (LVEF) \<30%
32. LV end diastolic diameter \> 70mm
33. Significant abnormalities of the sub-valvular apparatus.
34. Severe mitral annular or leaflets calcification
35. Left atrial or LV thrombus or vegetation
36. Severe right ventricular dysfunction
37. Severe tricuspid or aortic valve disease