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NCT Number: NCT04250857

HeartStart FRx Defibrillator Event Registry

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Philips

Monroeville, Pennsylvania, 15146, United States

Location status: Recruiting

Location contact

Barb Fink

CONTACT

[email protected]

724-708-7048

Gerrit Noordergraaf, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HeartStart FRX

Device

Automated External Defibrillator

Primary outcomes

  1. Algorithm accuracy

    Time frame: Up to 15 minutes after device placement

    Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.

  2. Shock Delivery

    Time frame: 1 day

    Percentage of events where a shock was delivered when indicated.

  3. Unexpected adverse events.

    Time frame: 1 day

    Frequency and severity of unexpected adverse events.

  4. Unanticipated adverse device effects (UADE)

    Time frame: 1 day

    Unanticipated adverse device effects (UADE)

Secondary outcomes

  1. Time Intervals

    Time frame: 1 day

    Measurements of device performance time intervals.

  2. Device Preparation

    Time frame: 1 day

    Percentage of events where the device prepared to shock.

  3. Shock Energy Delivered

    Time frame: 1 day

    The amount of shock energy delivered as measured in joules with each shock.

  4. Pad Replacement

    Time frame: 1 day

    Frequency of pad replacement.

  5. User

    Time frame: 1 day

    Frequency of user pressing the shock button.

Study contacts

Contact information is provided by the study sponsor or research team.

Barb Fink

CONTACT

[email protected]

724-708-7048

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2020
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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