A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
âś“. 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
âś“. Understands the study requirements and the treatment procedures and provides written informed consent
âś“. Subject agrees to complete all required scheduled follow-up visits.
Exclusion criteria
✕. Anatomy precluding safe placement of DurAVR™ THV
âś•. Pre-existing prosthetic mitral or tricuspid valve
âś•. Unicuspid, bicuspid or non-calcified aortic valve
âś•. Severe mitral or severe tricuspid regurgitation requiring intervention
âś•. Moderate to severe mitral stenosis
âś•. Hypertrophic obstructive cardiomyopathy
âś•. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment