Clinical Trial

DurAVR™ THV System: EMBARK Study

Name: DurAVR™ THV System: EMBARK Study — clinical trial record (NCT05182307)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Active, Not Recruiting

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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.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2021-12-20; most recent amendment 2026-06-23.

Trial Details

NCT Number	NCT05182307
Lead Sponsor	Anteris Technologies Ltd.
Conditions	Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
Enrollment	150 participants
Start Date	2021-11-15
Primary Completion	2028-01 (estimated)
Study Completion	2028-04 (estimated)
Updated on ClinicalTrials.gov	2026-06-26