HighLife™ Transcatheter Mitral Valve Replacement System Study

HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk

Multicenter feasibility study of the HighLife™ TMVR system.

This is an exploratory clinical study designed to evaluate the feasibility, safety and performance of the Highlife TMVR System in a population of patients with severe symptomatic mitral regurgitation, who are not suitable for surgical or approved percutaneous treatments according to the judgement of the Heart Team. The data gathered in this study will allow to evaluate the feasibility of mitral replacement using the HighLife™ TMVR system and characterize the safety and performance profile of the HighLife™ TMVR System.

All patients will be followed periodically up to 12 months after the intervention and long term safety and performance will be collected annually up to 5 years.

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