Munich Transcatheter Mitral Valve Safety and Effectiveness
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorP+F Products + Features GmbH
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Subject who is currently participating in an investigational study, other than this study
Subjects allergic to bovine tissue
Subjects with uncontrolled hypotension
Hemodynamic instability
Trial design
Design model
Single group
Treatments tested in this trial
MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM
DeviceThe 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Single-ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 5Other outcomes
1
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
Intraprocedural2
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, 4,53
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, 4,54
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, 4,5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
P+F Products + Features GmbH
Lead sponsor
Meditrial USA Inc.
Collaborator
Source ClinicalTrials.gov
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