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HeartStart HS1 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
    v8
  2. Re-verified, no change to tracked fieldsv7
  3. Primary endpoints: 2 to 5
    • Secondary endpoints: 4 to 12
    • Site contact updated
    v6
  4. Primary and study completion dates: Jan 2025 to Dec 2027v5
  5. 3 versions Re-verified since Nov 5, 2021, no change to tracked fieldsv2-v4
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data.
Trial Details
NCT Number NCT04840797
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