Sudden Cardiac Arrest
Conditions
Brief 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.
Interventions
DEVICEHeartStart FRX
Automated External Defibrillator
Sponsors
Heartstream US LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Algorithm accuracy | Up to 15 minutes after device placement | Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement. |
| Shock Delivery | 1 day | Percentage of events where a shock was delivered when indicated. |
| Unexpected adverse events. | 1 day | Frequency and severity of unexpected adverse events. |
| Unanticipated adverse device effects (UADE) | 1 day | Unanticipated adverse device effects (UADE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Intervals | 1 day | Measurements of device performance time intervals. |
| Device Preparation | 1 day | Percentage of events where the device prepared to shock. |
| Shock Energy Delivered | 1 day | The amount of shock energy delivered as measured in joules with each shock. |
| Pad Replacement | 1 day | Frequency of pad replacement. |
| User | 1 day | Frequency of user pressing the shock button. |
Countries
United States
Contacts
CONTACTBarb Fink
Outcome results
None listed