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HeartStart FRx Defibrillator Event Registry

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years later Dec 2027 → Dec 31, 2030
See other at-risk trials from Heartstream US LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 2027 to Dec 31, 2030
    • Sponsor changed: Philips Clinical & Medical Affairs Global to Heartstream US LLC
    • Site contact updated
    v10
  2. 2 versions Re-verified since Sep 11, 2024, no change to tracked fieldsv8-v9
  3. Primary and study completion dates: Dec 2024 to Dec 2027v7
  4. Re-verified, no change to tracked fieldsv6
  5. Primary and study completion dates: Dec 31, 2022 to Dec 2024v5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Primary and study completion dates: Dec 31, 2021 to Dec 31, 2022v3
  3. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.
Trial Details
NCT Number NCT04250857
Lead Sponsor Heartstream US LLC
Conditions
(from sponsor)		 Sudden Cardiac Arrest
Related terms Death, Sudden, Cardiac
Enrollment 1,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov