Feasibility Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
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to evaluate the feasibility, safety and performance of the HighLife 28mm Transcatheter Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
1. Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (≥ 3+) 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
Any stroke/TIA within 30 days
Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
Active infections requiring antibiotic therapy
Active ulcer or gastro-intestinal bleeding in the past 3 months
History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
Patients in whom TEE is not feasible
Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
Patient is unable to comply with the follow-up schedule and assessments
Participation in another clinical investigation at the time of inclusion
Patient has known allergies to the device components or contrast medium
Patient cannot tolerate anticoagulation or antiplatelet therapy
Patients with a life expectancy of less than 12 months due to non-cardiac conditions
Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months