DurAVR™ THV System: EMBARK Study

The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve.

The study will enroll up to 150 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.

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) ≤ 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
• 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.