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DurAVR™ THV System: EMBARK Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment target: 50 to 150v5 Show 5 more changesShow less
    • Primary completion date: Jan 2025 to Jan 2028
    • Study completion date: Jan 2025 to Apr 2028
    • Eligibility criteria revised
    • Study description revised
    • Study title revised
  2. Enrollment target: 10 to 50
    • Primary and study completion dates: Dec 2023 to Jan 2025
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Primary and study completion dates: Jun 2023 to Dec 2023
    • Study description revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05182307
Lead Sponsor Anteris Technologies Ltd.
Conditions
(from sponsor)		 Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
Related terms Aortic Valve Stenosis, Aortic Valve, Calcification of
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov