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โ† Trials
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HeartStart FRx Defibrillator Event Registry

Recruitingn/aAges any - anyAllHeartstream US LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • HeartStart FRX
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Where

1 site
Philips
Monroeville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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