HeartStart FRx Defibrillator Event Registry
ConditionSudden Cardiac Arrest
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHeartstream US LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
AED used for training purposes.
Trial population
Use of the HeartStart FRx AED is intended for the following populations in addition to adults: newborns, neonates, infant, children, and adolescents. It may also be used on pregnant women. Devices are located in public access spaces and with first responders around the world.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
HeartStart FRX
DeviceAutomated External Defibrillator
Treatment groups
1,400 Participants
are divided into 1 treatment groupGroup A: Suspected Sudden Cardiac Arrest1 intervention
Trial outcomes
Primary outcomes
1
Algorithm accuracy
Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.
Time frame
Up to 15 minutes after device placement2
Shock Delivery
Percentage of events where a shock was delivered when indicated.
Time frame
1 day3
Unexpected adverse events.
Frequency and severity of unexpected adverse events.
Time frame
1 day4
Unanticipated adverse device effects (UADE)
Unanticipated adverse device effects (UADE)
Time frame
1 daySecondary outcomes
1
Time Intervals
Measurements of device performance time intervals.
Time frame
1 day2
Device Preparation
Percentage of events where the device prepared to shock.
Time frame
1 day3
Shock Energy Delivered
The amount of shock energy delivered as measured in joules with each shock.
Time frame
1 day4
Pad Replacement
Frequency of pad replacement.
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov