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

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

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 olderRequires 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™ THVAnatomy 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 consentSubject 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:AnatomicalAnatomy precluding safe placement of DurAVR™ THVPre-existing prosthetic heart valve in any positionUnicuspid or bicuspid aortic valveSevere aortic regurgitationSevere mitral or severe tricuspid regurgitation requiring intervention.Moderate to severe mitral stenosis.Hypertrophic obstructive cardiomyopathyEchocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.Severe basal septal hypertrophy with outflow gradientClinicalEvidence of an acute myocardial infarction ≤ 30 days before the intended treatment.Determined inoperable/ineligible for surgery by the Heart TeamAny percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedureBlood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable statesUntreated clinically significant Coronary Artery Disease (CAD) requiring revascularizationCardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic supportNeed for emergency surgery for any reasonVentricular dysfunction with left ventricular ejection fraction (LVEF) < 30% as measured by resting echocardiogramRecent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).Symptomatic carotid or vertebral artery diseaseEnd stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.GI bleeding within the past 3 monthsA 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 mediaOngoing sepsis, including active endocarditis (Duke Criteria) [49]Subject refuses a blood transfusionLife expectancy < 12 months due to associated non-cardiac co-morbid conditionsOther medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consentSevere 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 trialSubject 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).