An interventional study of MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM in Mitral Regurgitation and Mitral Valve Disease, sponsored by P+F Products + Features GmbH. Not yet recruiting at 10 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by P+F Products + Features GmbH · Not applicable, Interventional, and Treatment
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.
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.
467 studies on the registry are indexed under Mitral Valve Insufficiency; 152 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 279 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →P+F Products + Features GmbH is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Moderate or severe mitral regurgitation (> 3+)
Exclusion Criteria:
General Conditions
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
UNOS stadium 1 heart transplantation or previous orthotopic heart transplantation
Anatomical and Functional
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
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.
Primary Safety Endpoints
The primary safety endpoint is to evaluate a 30-day major adverse events (MAE) rate, where MAE is a composite of the following device- or procedure-related events: * All-cause mortality * Stroke * Life-threatening bleeding (MVARC scale) * Major vascular complications * Major cardiac structural complications * Myocardial infarction or coronary ischemia requiring PCI or CABG * Stage 2 or 3 acute kidney injury (includes new dialysis) * Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressor or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for \>48 h. * Emergency surgery or re-intervention.
Time frame: 30 days
Secondary Safety Endpoints
Secondary safety endpoints include an evaluation at 90-day, 180-day, 1 year and annually at year 2, 3, 4 and 5 (inclusive of unscheduled visits): * Death, cardiac, non-cardiac * Stroke * Myocardial Infarction * Any device related complication/ dysfunction * New atrial fibrillation (AF) * New conduction disturbance requiring permanent pacemaker (PM) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Time frame: 90-day, 180-day, 1 year and annually at year 2, 3, 4 and 5
Secondary Performance Assessment
Technical success of the procedure, defined as successful access to the left atrium, delivery and deployment of the Munich Valve in the correct position and retrieval of delivery catheter, without significant mitral stenosis, LVOT obstruction or paravalvular MR documented by intraoperative imaging.
Time frame: Intraprocedural
Secondary Effectiveness Assessment: Reduction of mitral regurgitation
Reduction of mitral regurgitation (MR) to either optimal (0+ to trace) or acceptable
Time frame: 30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5
Secondary Effectiveness Assessment: Changes in Ejection Fraction
Changes in Ejection Fraction
Time frame: 30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5
Secondary Effectiveness Assessment: NYHAC
New York Heart Association Class
Time frame: 30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5
Secondary Effectiveness Assessment: KCCQ
Quality of Life Improvement vs. Baseline (Kansas City Cardiomyopathy Questionnaire, KCCQ - Appendix I)
Time frame: 30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5
Secondary Effectiveness Assessment: Hospitalization Rate
Rate of hospitalizations for heart failure
Time frame: 30-day, 90-day, 180-day, 1-year and annually at year 2, 3, 4,5
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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P+F Products + Features GmbH