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Clinical Trials in the USA / NCT04840797
Recruiting Observational

HeartStart HS1 Defibrillator* Event Registry

NCT04840797 · tracked via the Priya Life Science USA tracker
Sponsor
Heartstream US LLC
Phase
Observational
Started
2021-02-25
Last updated
2026-08-11

Condition(s) studied

Sudden Cardiac Arrest

Investigational drug(s) / intervention(s)

HeartStart HS1

HeartStart HS1: Automated External Defibrillator

Study summary

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

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Mean shock energy delivered in the pediatric population — 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.
  • Mean shock energy delivered in the adult population — 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.
  • 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 success — Up to 15 minutes during device placement
    Defibrillation success and the number of shocks required for success.

Trial sites (1)

FacilityCityRegionStatus
Philips Pittsburgh Pennsylvania Recruiting

More Heartstream US LLC trials in the USA

Pulse Detection in Cardiac Arrest Patients Using a Doppler Ultrasound Patch on the Carotid Artery Starting soon
HeartStart FRx Defibrillator Event Registry Recruiting

Other trials for the same condition

HeartStart FRx Defibrillator Event Registry Recruiting
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04840797 on ClinicalTrials.gov ↗ ← All trials in the USA