The Leaflex™ Standalone Study Protocol

Study Overview
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Brief Summary
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A prospective, multicenter, single-arm study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis. Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.

Official Title
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The Leaflex™ Standalone Study Protocol

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Leaflex™ Performer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with symptomatic, severe aortic stenosis who are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement. Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent. Exclusion Criteria: Moderate or greater aortic regurgitation. Anatomic contraindications. Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure. Aortic balloon valvuloplasty ≤ 3 months prior to index procedure. Stroke ≤ 12 months prior to index procedure. History of a myocardial infarction ≤ 6 weeks prior to index procedure. Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy. Hemodynamic instability. Hypertrophic cardiomyopathy with obstruction. Left ventricle ejection fraction <30%. Ongoing severe infection, including endocarditis, or sepsis. Life expectancy ≤ 12 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: Leaflex™ Performer<br> | Device: Leaflex™ Performer<br>* A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aortic valve area | assessed by echo | Baseline to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause mortality and all-cause stroke (VARC 2) | Composite | 30 days post procedure | 
| Rate of worsening of aortic regurgitation | by greater than 1 grade | Baseline to 30 days | 
| Rate of device related adverse events |  | 12 months | 
| Change in 6 minute walk test | distance (meters) | 1, 6 and 12 months | 
| Quality of Life Improvement | KCCQ | 1, 6 and 12 months | 
| Quality of Life Improvement | EQ5D | 1, 6 and 12 months | 
| Change in aortic valve area | assessed by echo | 30 days, 3, 6, 9 and 12 months | 
| Change in pressure gradients | assessed by echo | 30 days, 3, 6, 9 and 12 months |