Munich Transcatheter Mitral Valve Safety and Effectiveness

Official title

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

Overview

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.

Detailed description

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.

Interventions

• 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 rep

Primary outcome measures

• Primary Safety Endpoints [Time frame: 30 days]

Secondary outcome measures (1)

• Secondary Safety Endpoints [Time frame: 90-day, 180-day, 1 year and annually at year 2, 3, 4 and 5]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Argentina · 4 centers

• Fundación Favaloro — Buenos Aires
• Hospital Italiano De Buenos Aires — Buenos Aires
• Hospital César Milstein — Buenos Aires
• Hospital Fernandez/Sanatorio Milstein — Buenos Aires

Brazil · 3 centers

• Instituto Estadual De Cardiologia Aloysio De Castro — Rio de Janeiro
• Instituto Dante Pazzanese De Cardiologia — São Paulo
• Instituto Do Coração (InCor) De São Paulo — São Paulo

Chile · 3 centers

• Hospital Del Torax De Santiago — Santiago
• Hospital Dr Sotero Del Rio De Santiago — Santiago
• Hospital Las Higueras - Talcahuano — Talcahuano

Identifiers

NCT: NCT05871983 · CTP-MIT-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗