P+F Products + Features GmbH
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.
Mitral Regurgitation
Mitral Valve Disease
MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM
Not Applicable
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.
Study Type : | Interventional |
Estimated Enrollment : | 60 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical Evaluation of Safety and Effectiveness of the Munich Transcatheter Mitral Valve Replacement (TMVR) System |
Actual Study Start Date : | July 30, 2023 |
Estimated Primary Completion Date : | December 30, 2025 |
Estimated Study Completion Date : | December 30, 2029 |
Arm | Intervention/treatment |
---|---|
Experimental: Single-Arm This is a prospective, non-randomized, single-arm, international, multicenter, clinical study designed to evaluate the safety, efficacy, and performance of the P&F MUNICH TMVR System in a population of patients with moderate to severe symptomatic Mitral Regurgitation. |
Device: MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Fundación Favaloro
Buenos Aires, Argentina, C1093
Not yet recruiting
Hospital Italiano De Buenos Aires
Buenos Aires, Argentina, C1199ABB
Not yet recruiting
Hospital César Milstein
Buenos Aires, Argentina, C1221
Not yet recruiting
Hospital Fernandez/Sanatorio Milstein
Buenos Aires, Argentina, C1425AGP
Not yet recruiting
Instituto Estadual De Cardiologia Aloysio De Castro
Rio de Janeiro, Brazil, 22261-010
Not yet recruiting
Instituto Dante Pazzanese De Cardiologia
São Paulo, Brazil, 04012-909
Not yet recruiting
Instituto Do Coração (InCor) De São Paulo
São Paulo, Brazil, 05403-900
Not yet recruiting
Hospital Del Torax De Santiago
Santiago, Chile, 7500691
Not yet recruiting
Hospital Dr Sotero Del Rio De Santiago
Santiago, Chile, 8150215
Not yet recruiting
Hospital Las Higueras - Talcahuano
Talcahuano, Chile, 4270940