Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

Study Overview
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Brief Summary
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To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.

Detailed Description
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The primary objective is to assess the acute and long-term safety and feasibility of the DurAVR™ device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement as assessed by the Heart Team at the enrolling institutions. This is a prospective, non-randomized, single-arm, multi-center Study. Subjects will be consented for follow-up to 10 years.

Official Title
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Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

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

Intervention / Treatment
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* Device: DurAVRTM THV System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are eligible for entry in this study if ALL the following conditions are met: Symptomatic, severe native aortic stenosis in subjects 65 years or older Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon) Eligible for transfemoral delivery of the DurAVR™ THV Anatomy appropriate to accommodate safe placement of DurAVR™ THV (Preprocedural measurements by TTE and CT required: aortic annulus diameter 21-23 mm by CT) 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: Subjects are eligible for entry in this study if NONE of the following conditions are met: 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 < 1000 mm3), 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) < 30% 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 (Duke Criteria) [49] 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 is contraindicated for MDCT or MRI Scans. Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).

Ages Eligible for Study
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Minimum Age: 65 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: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, non-randomized, single-arm, multi-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DurAVR™ THV System<br>TAVR procedure | Device: DurAVRTM THV System<br>* The DurAVR™ Transcatheter Heart Valve (THV) is a balloon expandable transcatheter aortic valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality or disabling stroke | Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines | 30days | 
| Technical success | Freedom from mortality, successful device implant, and freedom from surgery or intervention related to the device. | Immediate post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Mortality would be reported as rate of death/mortality at 30days. | 30days | 
| Disabling stroke | Rate of disabling stroke according to VARC-3 Guidelines | 30days | 
| Major vascular, access-related, or cardiac structural complication | complications according to VARC-3 Guidelines | 30days | 
| VARC-3 Type 2-4 bleeding | Rates of Type 2, 3, and 4 bleeding according to VARC-3 guidelines | 30days | 
| Acute Kidney Injury stage 3 or 4 | AKI stage 3-4 according to VARC-3 guidelines | 30days | 
| Moderate or severe aortic regurgitation | aortic regurgitation according to VARC-3 guidelines | 30days | 
| New permanent pacemaker due to procedure related conduction abnormalities | Rate of pacemaker interventions in subjects experiencing conduction abnormalities | 30days | 
| Surgery or intervention related to the device, including aortic valve reintervention. | Device related interventions | 30days | 

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