Expanded 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

Study Overview
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Brief Summary
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to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.

Official Title
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Expanded 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

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: HighLife Transcatheter Mitral Valve Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>Single arm, non-randomized | Device: HighLife Transcatheter Mitral Valve Replacement<br>* Transcatheter Mitral Valve Replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Safety | Freedom from major adverse events | 30 days |