HeartStart FRx Defibrillator Event Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-04

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Sudden Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected Sudden Cardiac Arrest

All subject with suspected of a circulatory arrest for any cause.

HeartStart FRX

Intervention Type DEVICE

Automated External Defibrillator

Interventions

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HeartStart FRX

Automated External Defibrillator

Intervention Type DEVICE

Eligibility Criteria

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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