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Evolut PRO China Clinical Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. 2 versions Re-verified since Mar 10, 2025, no change to tracked fieldsv8-v9
  2. Results first posted: Nov 29, 2024v7 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: estimated 58 to confirmed 52
    • Study completion date: Nov 28, 2028 to May 15, 2028
    • Secondary endpoints revised (7)
    • Study description shortened, about 5 words
  3. Primary completion date changed from estimate of Mar 31, 2023 to Mar 17, 2023v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 59 to 58
    • Primary completion date: Feb 16, 2023 to Mar 31, 2023
    • Site details revised at 4 of 4 sites
    v5
  5. Primary completion date: Aug 1, 2022 to Feb 16, 2023
    • Study completion date: Oct 1, 2027 to Nov 28, 2028
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Enrollment target: 65 to 59
    • Study sites: 1 to 4
    • Primary completion date: Sep 30, 2022 to Aug 1, 2022
    • Study completion date: Oct 31, 2027 to Oct 1, 2027
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 30, 2021 to Jul 17, 2021
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve™ Evolut™ PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR).
Trial Details
NCT Number NCT04982588
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Severe, Symptomatic Aortic Stenosis
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov