HeartStart HS1 Defibrillator* Event Registry
ConditionSudden Cardiac Arrest
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHeartstream US LLC
About this trial
A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have been suspected of a circulatory arrest for any cause.
Disqualifiers
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.
Trial population
Anyone who is suspected of having a sudden cardiac arrest.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
HeartStart HS1
DeviceAutomated External Defibrillator
Treatment groups
1,400 Participants
are divided into 1 treatment groupGroup A: Suspected Sudden Cardiac Arrest1 intervention
Trial outcomes
Primary outcomes
1
Mean shock energy delivered in the pediatric population
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.
Time frame
Up to 15 minutes during device placement2
Mean shock energy delivered in the adult population
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.
Time frame
Up to 15 minutes during device placement3
The Patient Analysis System (PAS) shock advisory algorithm performance as determined by evaluation of the ECG as aligned with the device advisement.
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).
Time frame
Up to 15 minutes during device placement4
Accurate detection of shockable rhythms and facilitation of shocks.
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.
Time frame
Up to 15 minutes during device placementSecondary outcomes
1
Frequency and severity of unexpected adverse events
Frequency and severity of unexpected adverse events
Time frame
Up to 15 minutes during device placement2
Unanticipated adverse device effects (UADE)
Unanticipated adverse device effects (UADE)
Time frame
Up to 15 minutes during device placement3
Median operating time intervals
Median operating time intervals
Time frame
Up to 15 minutes during device placement4
Routine self-test performance/Battery Insertion self-test performance
Routine self-test performance/Battery Insertion self-test performance
Time frame
Up to 15 minutes during device placementSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov