Munich Transcatheter Mitral Valve Safety and Effectiveness

Ki vehet részt

• Age ≥ 18 years
• Moderate or severe mitral regurgitation (> 3+); For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml; For Secondary MR: EROA > 30 mm2 or regurgitant volume > 45ml (i.e., MR moderate or severe by ASE criteria)
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
• Subject is under guideline directed medical therapy for at least one month
• 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
• Subject meets the anatomical criteria for Munich TMVR System
• Patient is willing to participate in the study and provides signed informed consent

Ki nem vehet részt

• Intolerance to antiplatelet, anticoagulant or thrombolytic medications
• Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
• Acute myocardial infarction within the previous 30 day
• Any prior heart valve surgery or transcatheter mitral intervention
• Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
• Rheumatic heart disease or endocarditis within the previous 3 months
• CRT/ICD implant within 30 days
• UNOS stadium 1 heart transplantation or previous orthotopic heart transplantation; Anatomical and Functional
• General Conditions
• Subjects allergic to bovine tissue
• Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated and has an allergy to Nitinol alloys
• Bleeding diathesis or hypercoagulable state
• Active peptic ulcer or active gastrointestinal bleeding
• Renal insufficiency
• Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
• Subject with hepatic insufficiency
• Subject has a co-morbid illness that may result in a life expectancy of less than one year
• Active infection that requires antibiotic therapy
• Any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
• Untreated clinically significant coronary artery disease requiring revascularization
• Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
• Aortic or pulmonic valve disease requiring surgery
• Severe tricuspid or aortic valve disease
• Left Ventricular Ejection Fraction (LVEF) <30%
• 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
• Subject who is currently participating in an investigational study, other than this study
• Subjects with uncontrolled hypotension
• Hemodynamic instability
• Pulmonary artery systolic pressure >70 mmHg
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis
• Severe organic lesion with retracted chordae or congenital malformation and lack of valvular tissue
• Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
• NYHA class IVb
• LV end diastolic diameter > 70mm
• Significant abnormalities of the sub-valvular apparatus
• Severe mitral annular or leaflets calcification
• Left atrial or LV thrombus or vegetation
• Severe right ventricular dysfunction