Global Utilization And Registry Database for Improved heArt preservatioN

Study acronym: GUARDIAN
StatusEnrolling by Invitation
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2027 → Dec 31, 2028
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Record History

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  1. Primary completion pushed from Dec 31, 2027 to Dec 31, 2028 Show 6 more changesShow less
    • Enrollment increased: 3000 → 4000 participants
    • Trial arms changed: 2 → 3
    • Eligibility criteria expanded, about 6 words
    • Study description expanded, about 143 words
    • Site details revised at 2 of 22 sites
    • Publications: details revised at 5 of 5 entries
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2027
    • Study completion date: Dec 31, 2025 to Dec 31, 2029
    v7
  3. Study sites: 21 to 22v6
  4. Enrollment target: 800 to 3000
    • Primary endpoints: 4 to 5
    • Secondary endpoints revised (3)
    v5
  5. Primary completion date: Dec 31, 2022 to Dec 31, 2024
    • Study sites: 20 to 21
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    • Study description expanded, about 9 words
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 5 to 20v3
  2. Enrollment target: 500 to 800
    • Start date changed from estimate of Oct 30, 2019 to Feb 14, 2020
    • Study sites: 3 to 5
    v2
  1. Study First Submitted
  • 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.
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method. CONCERT DCD is a substudy designed to assess the safety and feasibility of a direct procurement method for donation after circulatory death (DCD) heart procurement (CONCERT DCD) that utilizes preservation in a SherpaPak Cardiac Transport System. This DCD Substudy will be limited to approved GUARDIAN-Heart Registry sites who have been qualified to participate. The DCD Substudy will include prospective recipient identification and documentation of informed consent.
Trial Details
NCT Number NCT04141605
Lead Sponsor Paragonix Technologies
Conditions
(from sponsor)		 Heart Diseases, Heart Failure, Heart Defects, Congenital
Related terms Heart Defects, Congenital, Heart Diseases, Heart Failure
Enrollment 4,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov