DurAVR™ THV System: First-In-Human Study

Study Overview
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Brief Summary
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A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.

Detailed Description
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The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve. The study will enroll up to 25 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.

Official Title
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Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: First In Human Study

Conditions
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Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification

Intervention / Treatment
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* Device: DurAVR™ THV System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic, severe aortic stenosis Eligible for delivery of the DurAVR™ THV Anatomy appropriate to accommodate safe placement of DurAVR™ THV Understands the study requirements and the treatment procedures and provides written informed consent. Subject agrees to complete all required scheduled follow-up visits. Exclusion Criteria: Anatomical Anatomy precluding safe placement of DurAVR™ THV Pre-existing prosthetic heart valve in any position Unicuspid or bicuspid aortic valve Severe aortic regurgitation Severe mitral or severe tricuspid regurgitation requiring intervention Moderate to severe mitral stenosis Hypertrophic obstructive cardiomyopathy Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment Severe basal septal hypertrophy with outflow gradient Clinical Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment Determined inoperable/ineligible for surgery by the Heart Team Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support Need for emergency surgery for any reason Ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 40% as measured by resting echocardiogram Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA) Symptomatic carotid or vertebral artery disease End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min GI bleeding within the past 3 months A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, nitinol (titanium or nickel), ticlopidine and clopidogrel, contrast media Ongoing sepsis, including active endocarditis Subject refuses a blood transfusion Life expectancy < 12 months due to associated non-cardiac co-morbid conditions Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits) Currently participating in an investigational drug or another investigational device trial Subject belongs to a vulnerable population.
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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>DurAVR™ THV System | Device: DurAVR™ THV System<br>* Transcatheter Aortic Valve Implantation (TAVI) Procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DurAVR™ prosthetic heart valve implant | Number of subjects for which a single DurAVR™ prosthetic heart valve was correctly positioned into the proper anatomical location | Immediate post procedure | 
| Hemodynamic performance | Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI) | Immediate post procedure | 
| All-cause mortality | All-cause mortality | 30 days | 
| All-cause mortality | All-cause mortality | 1 year | 
| Myocardial infarction | Myocardial infarction | 30 days | 
| Myocardial infarction | Myocardial infarction | 1 year | 
| Stroke | Disabling Stroke (VARC-3 Guidelines) | 30 days | 
| Stroke | Disabling Stroke (VARC-3 Guidelines) | 1 year | 
| Life-threatening bleeding | Life-threatening bleeding (VARC-3 Guidelines) | 30 days | 
| Life-threatening bleeding | Life-threatening bleeding (VARC-3 Guidelines) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, TAVR, Transcatheter Aortic Valve Implantation, Transcatheter valve