HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

Study Overview
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Brief Summary
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Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

Detailed Description
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Study to assess the feasibility, safety, and performance of the HighLife CLARITY TSMV, and its deliver systems, in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment according to the local multidisciplinary Heart Team decision, and who are at high risk for potential LVOT obstruction(LVOTO).

Official Title
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HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: CLARITY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Moderate-severe or severe mitral regurgitation (≥ 3+) Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team 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 Patient meets the anatomical criteria for HighLife valve Patient is willing to participate in the study and provides signed informed consent Patients with a high risk for LVOTO 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: Treatment<br>Trans-septal mitral valve replacement | Device: CLARITY<br>* Trans-septal mitral valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of subjects meeting Technical Success | Successful vascular access, delivery and retrieval of the HighLife delivery systems Deployment and correct positioning of the HighLife 28mm CLARITY TSMV Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE Successful vascular access, delivery and retrieval of the HighLife delivery systems Deployment and correct positioning of the HighLife 28mm CLARITY TSMV Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE | 24 hours |