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NCT Number: NCT04840797

HeartStart HS1 Defibrillator* Event Registry

A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) & HeartStart Home (Model M5068A) Defibrillator device data.

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Key information

Conditions

Sudden Cardiac Arrest Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Philips

Pittsburgh, Pennsylvania, 15206, United States

Location status: Recruiting

Location contact

Chase Wennick

CONTACT

[email protected]

617-398-7347

Gerrit Nordergraaf, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

The objective of this PMCF (Post Market Clinical Follow-up) prospective collection of post-event data registry is to confirm the safety and performance as expressed in the energy delivery by the HeartStart HS1 Defibrillator (HeartStart OnSite and Home models in North America) in the population for the device's intended use in reference to its commercial labeling, and in relationship to the type of pads attached to the device.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have been suspected of a circulatory arrest for any cause.
  • Have had HeartStart HS1 Defibrillator with electrodes:

Adult SMART Pads Cartridge [REF: M5071A], Infant/Child SMART Pads Cartridge (REF:M5072A) applied to their body and powered up with HS1 battery (Model M5070A), regardless of whether a defibrillation shock was delivered

Exclusion criteria

  • Subjects will be excluded if any of the following are present:
  • AED or pad use other than the HeartStart HS1 Defibrillator with above referenced Philips electrode pads. Note: Use of a device other than the Philips HeartStart HS1 AED does not preclude enrollment if the AED or an Advanced Life Support defibrillator was used after the HeartStart HS1 AED.
  • AED used for training purposes.

Treatment and study plan

HeartStart HS1

Device

Automated External Defibrillator

Primary outcomes

  1. Mean shock energy delivered in the pediatric population

    Time frame: Up to 15 minutes during device placement

    Mean of shock energy delivered, when the pediatric defibrillation pads were attached to the AED as intended for infants and children under 25 kilograms / 55 pounds or 0-8 years old.

  2. Mean shock energy delivered in the adult population

    Time frame: Up to 15 minutes during device placement

    Mean of shock energy delivered, when the adult defibrillation pads were attached to the AED as intended for in children and adults over 25 kilograms / 55 pounds or greater than 8 years old.

  3. The Patient Analysis System (PAS) shock advisory algorithm performance as determined by evaluation of the ECG as aligned with the device advisement.

    Time frame: Up to 15 minutes during device placement

    Performance is defined by the sensitivity and specificity; positive predictive value and false positive rate will be reported for each rhythm category (as defined by device labeling).

  4. Accurate detection of shockable rhythms and facilitation of shocks.

    Time frame: Up to 15 minutes during device placement

    The percentage of events where a shockable rhythm was identified by the device, the device advised a shock, and the device delivered a shock when the shock button was pressed.

  5. Defibrillation success

    Time frame: Up to 15 minutes during device placement

    Defibrillation success and the number of shocks required for success.

Secondary outcomes

  1. Frequency and severity of unexpected adverse events

    Time frame: Up to 15 minutes during device placement

    Frequency and severity of unexpected adverse events

  2. Unanticipated adverse device effects (UADE)

    Time frame: Up to 15 minutes during device placement

    Unanticipated adverse device effects (UADE)

  3. Median operating time intervals

    Time frame: Up to 15 minutes during device placement

    Median operating time intervals

  4. Routine self-test performance/Battery Insertion self-test performance

    Time frame: Up to 15 minutes during device placement

    Routine self-test performance/Battery Insertion self-test performance

  5. Device arming after shock advisement.

    Time frame: Up to 15 minutes during device placement

    The percentage of events where the device advised a shock and the device armed.

  6. Energy delivered consistent with device labeling

    Time frame: Up to 15 minutes during device placement

    The percentage of defibrillations in which the energy delivered was consistent with device labeling.

  7. Pad replacement notification

    Time frame: Up to 15 minutes during device placement

    Number of events in which pads were replaced at any time during the event after the user is prompted to do so by the device

  8. Shock button effectively pressed after shock advisement

    Time frame: Up to 15 minutes during device placement

    The percentage of events where a shock was recommended by the device and the shock button was pressed.

  9. Indicators of battery status/depletion (device logged data)

    Time frame: Up to 15 minutes during device placement

    Percentage of events that include indicators of battery status/depletion (device logged data)

  10. Aborted shocks because of low or high impedance

    Time frame: Up to 15 minutes during device placement

    Percentage of aborted shocks because of low or high impedance

  11. CPR guidance initiated (i-button pushed)

    Time frame: Up to 15 minutes during device placement

    Percentage of events where CPR guidance was initiated (i-button pushed)

  12. CPR activity

    Time frame: Up to 15 minutes during device placement

    Percentage of events where CPR is performed during CPR guidance

Study contacts

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

Barbara Fink

CONTACT

[email protected]

724-708-7048

Chase Wennick

CONTACT

[email protected]

617-398-7347

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 12, 2021
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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