A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System

Inclusion criteria

Native Aortic Stenosis Cohorts:

• The subject is a candidate for TAVR using the DurAVR® THV System, and a SAPIEN series THV system or an Evolut series THV System.
• The local Heart Team agrees that the subject has an appropriate indication for, and will benefit from, TAVR due to native calcific valve severe aortic stenosis.
• Subject understands the study requirements and the treatment procedure and provides written informed consent.

ViV Registry Cohort:

• Severe degeneration of a surgically implanted aortic bioprosthetic valve.
• Subject requires aortic valve replacement and is high surgical risk and is indicated for TAVR Valve-in-Valve procedure as determined by the Heart Team.
• Subject understands the study requirements and the treatment procedure and provides written informed consent.

Exclusion criteria

Native Aortic Stenosis Cohorts:

• Native aortic annulus size unsuitable for study THVs (investigational or control) based on CT imaging analysis.
• Access vessel characteristics that would preclude safe placement of the introducer sheath (investigational or control).
• Evidence of an acute myocardial infarction 30 days before randomization.
• AV is unicuspid, Type 0 bicuspid, or is non-calcified.
• Severe total aortic regurgitation
• Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis.
• Pre-existing mechanical or bioprosthetic valve in any position.
• Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
• Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
• Active bacterial endocarditis in the last 3 months.
• Estimated life expectancy (after TAVR) <12 months.
• Subject is not a candidate for both arms (investigational and control) of the study.
• Subject belongs to a vulnerable population

ViV Registry Cohort:

• Anatomy precluding safe placement of DurAVR THV.
• Pre-existing prosthetic heart valve in the mitral, tricuspid or pulmonary position.
• Severe mitral or tricuspid regurgitation or ≥ moderate mitral stenosis
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation.
• Failing surgical aortic bioprosthesis is unstable, rocking, or not structurally intact.
• Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
• Untreated clinically significant coronary artery disease (CAD) requiring revascularization.
• Need for emergency surgery for any reason
• GI bleeding within the past 3 months.
• Active bacterial endocarditis in the last 3 months.
• Estimated life expectancy (after TAVR) <12 months.
• Subject belongs to a vulnerable population.