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Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study

Study acronym: DurAVR™ EFS
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 2 versions Re-verified since Apr 3, 2026, no change to tracked fieldsv7-v8
  2. Minor Primary completion date changed from estimate of Nov 2023 to Dec 29, 2023v6
  3. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 7 to 5
    • Primary completion date: Aug 2023 to Nov 2023
    • Start date changed from estimate of Jul 2023 to Aug 7, 2023
    v5
  4. Notable Start date: May 2023 to Jul 2023
    • Study sites: 4 to 7
    v4
  5. Minor Study sites: 0 to 4v3
  6. Notable Start date: Feb 2023 to May 2023v2
  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
Trial Details
NCT Number NCT05712161
Lead Sponsor Anteris Technologies Ltd.
Conditions
(from sponsor)
Aortic Stenosis, Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
Related terms Aortic Valve Stenosis, Aortic Valve, Calcification of
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov