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Clinical Trial Summary

A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.


Clinical Trial Description

The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve. The study will enroll up to 10 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05182307
Study type Interventional
Source Admedus Regen Pty Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date November 15, 2021
Completion date June 2023

See also
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