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A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System

Study acronym: PARADIGM
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial sites reduced: 14 → 1 locationsv14
  2. Study sites: 13 to 14v13
  3. Trial sites expanded: 8 → 13 locationsv12
  4. Study sites: 6 to 8v11
  5. Re-verified, no change to tracked fieldsv10
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 5 to 6v9
  2. Study sites: 4 to 5v8
  3. Study sites: 3 to 4v7
  4. Study sites: 1 to 3v6
  1. Primary endpoint(s) modifiedv5 Show 15 more changesShow less
    • Primary endpoint(s) modified
    • Phase changed: not specified → not applicable
    • Phase changed: not applicable → not specified
    • Sponsor changed: [Redacted] to Anteris Technologies Ltd.
    • Sponsor changed: Anteris Technologies Ltd. to [Redacted]
    • Trial status changed: Withheld → Recruiting
    • Trial status changed: Recruiting → Withheld
    • Enrollment changed: None → 1650
    • Enrollment changed: 1650 → None
    • Trial arms changed: 0 → 2
    • Trial arms changed: 2 → 0
    • Primary completion date: Dec 2027
    • Study completion date: Mar 2038
    • Start date: Oct 21, 2025
    • Study title revised
  2. Lead sponsor: Anteris Technologies Ltd. to [Redacted]v4 Show 5 more changesShow less
    • Trial status: Recruiting to Withheld
    • Primary completion date: Dec 2027 to not stated
    • Study completion date: Mar 2038 to not stated
    • Start date: Oct 21, 2025 to not stated
    • Study title revised
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Sep 2027 to Dec 2027
    • Study completion date: Dec 2037 to Mar 2038
    • Start date changed from estimate of Oct 2025 to Oct 21, 2025
  4. Enrollment target: 1600 to 1650v2 Show 4 more changesShow less
    • Start date: Sep 2025 to Oct 2025
    • Interventions: TAVR with DurAVR THV (Device), TAVR with SAPIEN THV series or the Evolut THV series (Device) to TAVR with DurAVR® THV (Device), TAVR with SAPIEN THV series or the Evolut THV series (Device)
    • Secondary endpoints: 6 to 5
    • Study title expanded, about 1 word
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic Valve Replacement (TAVR), will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved Transcatheter Heart Valve (THV) from the SAPIEN series or the Evolut series and followed for 10 years. After completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'. Up to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.
Trial Details
NCT Number NCT07194265
Lead Sponsor Anteris Technologies Ltd.
Conditions
(from sponsor)		 Severe Aortic Stenosis, Valve-in-valve Procedures
Related terms Aortic Valve Stenosis, Aortic Valve, Calcification of
Enrollment 1,650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov