Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

General Conditions
Subject who is currently participating in an investigational study, other than this study
Subjects allergic to bovine tissue
Subjects with uncontrolled hypotension
Hemodynamic instability
Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated and has an allergy to Nitinol alloys
Intolerance to antiplatelet, anticoagulant or thrombolytic medications
Bleeding diathesis or hypercoagulable state
Active peptic ulcer or active gastrointestinal bleeding
Pulmonary artery systolic pressure \>70 mmHg
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
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
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
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis
Severe organic lesion with retracted chordae or congenital malformation and lack of valvular tissue
Any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
Untreated clinically significant coronary artery disease requiring revascularization
Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
Aortic or pulmonic valve disease requiring surgery
CRT/ICD implant within 30 days
NYHA class IVb
UNOS stadium 1 heart transplantation or previous orthotopic heart transplantation
Anatomical and Functional
Left Ventricular Ejection Fraction (LVEF) \<30%
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
Severe tricuspid or aortic valve disease

Intervenciones

device

MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM

The replacement valve consists of a self-expanding, tri-leaflet, dry bovine -pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The key characteristics of Munich valve are: * Nitinol stent frame * Bovine pericardium * Polyester skirt * Anchoring system allows anchoring the frame to the annulus * Hooks are used to reduce the mobility of the native leaflets and decrease risk of embolization. The Munich TMVR system design proposed for this clinical investigation represents a significant evolution from previous TMVR designs: * Transfemoral / transseptal access * Self-expanding * Dry pericardium (can be pre-loaded) * No anchors * 27 Fr delivery catheter ( * Sizes: 40/48/55mm * Height 30 mm The valve is available in 3 sizes with a 30mm profile and has been designed to reduce the complexity of implantation in comparison to other TMVR systems.

Ubicaciones

Fundación Favaloro

Buenos Aires, Argentina

Oscar Mendiz, MD · omendiz@ffavaloro.org

Hospital Italiano De Buenos Aires

Buenos Aires, Argentina

Carla Agatiello, MD · carla.agatiello@hospitalitaliano.org.ar

Hospital César Milstein

Buenos Aires, Argentina

Miguel Payaslian, MD · mopian@yahoo.com.ar

Hospital Fernandez/Sanatorio Milstein

Buenos Aires, Argentina

Miguel Payaslian, MD · mopian@yahoo.com.ar

Clinical Evaluation of Safety and Effectiveness of the Munich Transcatheter Mitral Valve Replacement (TMVR) System

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM

Ubicaciones

Fundación Favaloro

Hospital Italiano De Buenos Aires

Hospital César Milstein

Hospital Fernandez/Sanatorio Milstein

Patrocinadores

Contactos

Monica E Tocchi, MPH, PhD

Monica Tocchi, MD