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
Qualifiers
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
Treatments tested in this trial
- MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
P+F Products + Features GmbH
Lead sponsor
Meditrial USA Inc.
Collaborator
Source ClinicalTrials.gov