HeartStart HS1 Defibrillator* Event Registry

Recruiting

• Conditions: Sudden Cardiac Arrest
• Interventions: Device: HeartStart HS1

• Registration Number: NCT04840797
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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.

Study Timeline

• Study Start: 2021-02-25
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected Sudden Cardiac Arrest	HeartStart HS1	All subjects with suspected of a circulatory arrest of any cause.

Primary Outcome Measures

Name	Time	Method
Defibrillation success	Up to 15 minutes during device placement	Defibrillation success and the number of shocks required for success.
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).
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.
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.

Secondary Outcome Measures

Name	Time	Method
Unanticipated adverse device effects (UADE)	Up to 15 minutes during device placement	Unanticipated adverse device effects (UADE)
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.
CPR guidance initiated (i-button pushed)	Up to 15 minutes during device placement	Percentage of events where CPR guidance was initiated (i-button pushed)
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 activity	Up to 15 minutes during device placement	Percentage of events where CPR is performed during CPR guidance
Median operating time intervals	Up to 15 minutes during device placement	Median operating time intervals
Frequency and severity of unexpected adverse events	Up to 15 minutes during device placement	Frequency and severity of unexpected adverse events
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)
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.

Trial Locations

Locations (1)

Philips; 🇺🇸 Pittsburgh, Pennsylvania, United States