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DurAVR™ THV EU-EFS

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Final enrollment: 15 participants (planned 40) Show 4 more changesShow less
    • Primary completion date changed from estimate of Jul 2026 to Jun 11, 2026
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Study description revised
  2. Primary completion date: Jun 2025 to Jul 2026v3 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Study completion date: Oct 2030 to Aug 2031
    • Start date changed from estimate of Oct 2024 to Jan 21, 2025
  3. Re-verified, no change to tracked fieldsv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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, 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.
Trial Details
NCT Number NCT06510855
Lead Sponsor Anteris Technologies Ltd.
Conditions
(from sponsor)		 Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure, Aortic Valve Disease
Related terms Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve, Calcification of
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov