HeartStart FRx Defibrillator Event Registry
Eligible age
All ages
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Heartstream US LLC
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
- ✕ AED used for training purposes.
Where it's recruiting
Monroeville
Source: ClinicalTrials.gov · NCT04250857 · last updated 2026-08-11