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HeartStart HS1 Defibrillator Event Registry for Sudden Cardiac Arrest

This study is an observational registry looking at the performance and safety of the HeartStart HS1 Defibrillator (also known as HeartStart OnSite and HeartStart Home models). Researchers want to understand how much shock energy the device delivers to both children and adults during a sudden cardiac arrest. They will also check if the device's shock advisory system works correctly by comparing its recommendations with actual heart rhythm readings. You could be included in this study if you experienced a suspected circulatory arrest (when your heart stops pumping blood) and had a HeartStart HS1 Defibrillator applied to you, regardless of whether a shock was given.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatment. It aims to include 1400 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Information will be collected for up to 15 minutes during device placement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04840797

HeartStart HS1 Defibrillator* Event Registry

Recruiting
Not specifiedAll AgesObservational
Heartstream US LLC
~1,400 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:HeartStart HS1

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean shock energy delivered in the pediatric population
Measured over Up to 15 minutes during device placement
+4 more outcomes measured

Conditions

Sudden Cardiac Arrest

Explore related trials

Sudden Cardiac Arrest

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Gerrit Noordergraaf, MD PhD · PRINCIPAL_INVESTIGATOR · Philips Healthcare

Who to contact

Chase Wennick
[email protected]
617-398-7347
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Mean shock energy delivered in the pediatric populationUp 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.

  • Mean shock energy delivered in the adult populationUp 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.

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

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

  • Defibrillation successUp to 15 minutes during device placement

    Defibrillation success and the number of shocks required for success.