HeartStart FRx Defibrillator Event Registry

  • STATUS
    Recruiting
  • participants needed
    1400
  • sponsor
    Philips Clinical & Medical Affairs Global
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Updated on 19 February 2024
See if I qualify
shock
circulatory arrest
defibrillation

Summary

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.

Details
Condition Sudden Cardiac Death
Age 100years or below
Treatment HeartStart FRX
Clinical Study IdentifierNCT04250857
SponsorPhilips Clinical & Medical Affairs Global
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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