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Recruiting NCT04250857

HeartStart FRx Defibrillator Event Registry

— Observational Sudden Cardiac Arrest

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HeartStart FRX.
Who it may be relevant to
Registry conditions: Sudden Cardiac Arrest. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device HeartStart FRX
    Automated External Defibrillator

Primary outcome measures

  • Algorithm accuracy [Time frame: Up to 15 minutes after device placement]
  • Shock Delivery [Time frame: 1 day]
  • Unexpected adverse events. [Time frame: 1 day]
  • Unanticipated adverse device effects (UADE) [Time frame: 1 day]
Secondary outcome measures (5)
  • Time Intervals [Time frame: 1 day]
  • Device Preparation [Time frame: 1 day]
  • Shock Energy Delivered [Time frame: 1 day]
  • Pad Replacement [Time frame: 1 day]
  • User [Time frame: 1 day]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Philips — Monroeville

Identifiers

NCT: NCT04250857 · MATC-ECR-Registry-2018-10295

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗