Tests a new heart valve device for people with leaky or faulty mitral valves
Tests a catheter-delivered replacement mitral valve in adults with a damaged mitral valve.
Plain-language title generated from the registry record
Registry title: Munich Transcatheter Mitral Valve Safety and Effectiveness
Key facts
- Where
- Rio de Janeiro and São Paulo, BrazilSee the 3 sites
Where in Brazil
- Instituto Estadual De Cardiologia Aloysio De CastroRio de Janeiro, BrazilNo longer taking part
- Instituto Dante Pazzanese de CardiologiaSão Paulo, BrazilNo longer taking part
- Instituto Do Coração (InCor) De São PauloSão Paulo, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- P+F Products + Features GmbH
- Trial code
- NCT05871983
- Record updated
- 11 July 2023
- Original description
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.Read full original descriptionShow less
Clinical Evaluation of Safety and Effectiveness of the Munich Transcatheter Mitral Valve Replacement (TMVR) System
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.
Inclusion: 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: 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.