Sudden Cardiac Arrest
Conditions
Keywords
AED, Post -Market, Cardiology
Brief summary
A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) & HeartStart Home (Model M5068A) Defibrillator device data.
Detailed description
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.
Interventions
DEVICEHeartStart HS1
Automated External Defibrillator
Sponsors
Heartstream US LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of unexpected adverse events | Up to 15 minutes during device placement | Frequency and severity of unexpected adverse events |
| Unanticipated adverse device effects (UADE) | Up to 15 minutes during device placement | Unanticipated adverse device effects (UADE) |
| Median operating time intervals | Up to 15 minutes during device placement | Median operating time intervals |
| Routine self-test performance/Battery Insertion self-test performance | Up to 15 minutes during device placement | Routine self-test performance/Battery Insertion self-test performance |
| Device arming after shock advisement. | Up to 15 minutes during device placement | The percentage of events where the device advised a shock and the device armed. |
| Energy delivered consistent with device labeling | Up to 15 minutes during device placement | The percentage of defibrillations in which the energy delivered was consistent with device labeling. |
| Pad replacement notification | 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 |
| Shock button effectively pressed after shock advisement | 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. |
| Indicators of battery status/depletion (device logged data) | Up to 15 minutes during device placement | Percentage of events that include indicators of battery status/depletion (device logged data) |
| Aborted shocks because of low or high impedance | Up to 15 minutes during device placement | Percentage of aborted shocks because of low or high impedance |
| CPR guidance initiated (i-button pushed) | Up to 15 minutes during device placement | Percentage of events where CPR guidance was initiated (i-button pushed) |
| CPR activity | Up to 15 minutes during device placement | Percentage of events where CPR is performed during CPR guidance |
Countries
United States
Contacts
CONTACTChase Wennick
CONTACTBarbara Fink
PRINCIPAL_INVESTIGATORGerrit Noordergraaf, MD PhD
Philips Healthcare
Outcome results
None listed