Philips
Monroeville, Pennsylvania, 15146, United States
Location status: Recruiting
NCT Number: NCT04250857
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.
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Observational
Monroeville, Pennsylvania, 15146, United States
Location status: Recruiting
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Automated External Defibrillator
Time frame: Up to 15 minutes after device placement
Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.
Time frame: 1 day
Percentage of events where a shock was delivered when indicated.
Time frame: 1 day
Frequency and severity of unexpected adverse events.
Time frame: 1 day
Unanticipated adverse device effects (UADE)
Time frame: 1 day
Measurements of device performance time intervals.
Time frame: 1 day
Percentage of events where the device prepared to shock.
Time frame: 1 day
The amount of shock energy delivered as measured in joules with each shock.
Time frame: 1 day
Frequency of pad replacement.
Time frame: 1 day
Frequency of user pressing the shock button.
Contact information is provided by the study sponsor or research team.
Philips Clinical & Medical Affairs Global
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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