An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal
 Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation
 who are at high risk for surgical treatment.
Inclusion Criteria:

 -  1. Age ≥ 18 years 2. Moderate-severe 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-severe or severe by ASE criteria) 3. Patient has New York Heart
 Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under
 guideline directed medical therapy, as reviewed and confirmed by the local
 multidisciplinary Heart Team, for at least one month 5. Patient is high-risk for
 open-heart surgery based on the assessment of the multidisciplinary Heart Team
 using standard scoring systems and consideration of co-morbidities, frailty, and
 disability 6. Patient meets the anatomical criteria for HighLife valve 7. Patient
 is willing to participate in the study and provides signed informed consent

 Exclusion Criteria:

 1. Any stroke/TIA within 30 days

 2. Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)

 3. Active infections requiring antibiotic therapy

 4. Active ulcer or gastro-intestinal bleeding in the past 3 months

 5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion

 6. Patients in whom TEE is not feasible

 7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.

 8. Patient is unable to comply with the follow-up schedule and assessments

 9. Participation in another clinical investigation at the time of inclusion

 10. Patient has known allergies to the device components or contrast medium

 11. Patient cannot tolerate anticoagulation or antiplatelet therapy

 12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions

 13. Patient had permanent pacemaker, or similar device with implantable cardiac leads
 (i.e. resynchronization therapy) within the last 3 months

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