An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Study Overview
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Brief Summary
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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.

Official Title
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An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: HighLife Transcatheter Mitral Valve Replacment


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+) 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: 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single<br> | Device: HighLife Transcatheter Mitral Valve Replacment<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 |