HighLife™ Transcatheter Mitral Valve Replacement System Study
Mitral Valve Regurgitation, Mitral Valve Insufficiency
About this trial
This is an interventional treatment trial for Mitral Valve Regurgitation
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Severe mitral regurgitation
- New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
- Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
- Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
- Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
- Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE
Main Exclusion Criteria:
- Mitral stenosis
- Rheumatic valve disease
- Severe calcifications of the mitral annulus and/or mitral leaflets
- Prior surgical or interventional treatment of the mitral valve
- Unsuitable anatomy for the transapical access
- Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
- Untreated clinically significant coronary artery disease requiring revascularization
- LVEF < 30%
- LVEDD > 70mm
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Hypertrophic Obstructive Cardiomyopathy (HOCM)
- Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure
Sites / Locations
- CHRU Lille
- Hôpital Privé Jacques Cartier
- CHU Nantes
- Groupe Hospitalier Pitié-Salpétrière Institut de Cardiologie
- CHU Rennes Pontchaillou
- CHU Toulouse Rangueil
- Universitätsklinikum
- Universitäres Herzzentrum Hamburg GmbH (UHZ)
- Herzzentrum Leipzig
- Deutsches Herzzentrum München des Freistaates Bayern
Arms of the Study
Arm 1
Experimental
transcatheter mitral valve replacement
HighLife TMVR System is a novel and innovative approach developed as an alternative treatment for severe MR when medical treatment is maximal and surgical interventions not possible or at high risk. The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a sub-annular implant (SAI), and their delivery systems and loading tools. The HighLife Valve is a 31 mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI).