HeartStart FRx Defibrillator Event Registry
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.
Conditions:
🦠 Sudden Cardiac Arrest
🗓️ Study Start (Actual) 4 November 2019
🗓️ Primary Completion (Estimated) December 2027
✅ Study Completion (Estimated) December 2027
👥 Enrollment (Estimated) 1400
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Monroeville, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause
    • * Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered

    Exclusion Criteria:

    • * AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
    • * AED used for training purposes.
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 December 2019
  • First Submitted that Met QC Criteria 30 January 2020
  • First Posted 31 January 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 September 2023
  • Last Update Posted 29 September 2023
  • Last Verified September 2023