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

Who can take part

• 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

Who cannot take part

• Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
• Need for emergency surgery for any reason
• Currently participating in an investigational drug or another investigational device trial
• Subjects are eligible for entry in this study if NONE of the following conditions are met:; Anatomical
• Pre-existing prosthetic heart valve in any position
• Determined inoperable/ineligible for surgery by the Heart Team
• Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• Symptomatic carotid or vertebral artery disease
• 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
• 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)
• Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
• Ventricular dysfunction with left ventricular ejection fraction (LVEF) < 30% as measured by resting echocardiogram
• End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min
• 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)
• Anatomy precluding safe placement of DurAVR™ THV
• 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
• Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• Ongoing sepsis, including active endocarditis (Duke Criteria) [49]
• Subject refuses a blood transfusion
• Subject is contraindicated for MDCT or MRI Scans