DurAVR™ THV EU-EFS

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

The study will enroll up to 40 subjects with severe, symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves, with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.

Subjects will be consented for follow-up to 5 years.

Inclusion criteria

• Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
• Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
• Eligible for transfemoral 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

• Anatomy precluding safe placement of DurAVR™ THV
• Pre-existing prosthetic mitral or tricuspid valve
• Unicuspid, bicuspid or non-calcified aortic valve
• 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
• 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
• Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• End-stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min
• GI bleeding within the past 3 months
• Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months
• Life expectancy < 12 months due to associated non-cardiac co-morbid conditions