Clinical trial NCT04840797: HeartStart HS1 Defibrillator* Event Registry
Official title: HeartStart HS1 Defibrillator* Event Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sudden Cardiac Arrest
Keywords: AED
Post -Market
Cardiology
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone who is suspected of having a sudden cardiac arrest.

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.

Eligibility criteria: 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 outcomes:
measure: Mean shock energy delivered in the pediatric population
timeFrame: Up to 15 minutes during device placement
measure: Mean shock energy delivered in the adult population
timeFrame: Up to 15 minutes during device placement
measure: The Patient Analysis System (PAS) shock advisory algorithm performance as determined by evaluation of the ECG as aligned with the device advisement.
timeFrame: Up to 15 minutes during device placement
measure: Accurate detection of shockable rhythms and facilitation of shocks.
timeFrame: Up to 15 minutes during device placement
measure: Defibrillation success
timeFrame: Up to 15 minutes during device placement
Secondary outcomes:
measure: Frequency and severity of unexpected adverse events
timeFrame: Up to 15 minutes during device placement
measure: Unanticipated adverse device effects (UADE)
timeFrame: Up to 15 minutes during device placement
measure: Median operating time intervals
timeFrame: Up to 15 minutes during device placement
measure: Routine self-test performance/Battery Insertion self-test performance
timeFrame: Up to 15 minutes during device placement
measure: Device arming after shock advisement.
timeFrame: Up to 15 minutes during device placement
measure: Energy delivered consistent with device labeling
timeFrame: Up to 15 minutes during device placement
measure: Pad replacement notification
timeFrame: Up to 15 minutes during device placement
measure: Shock button effectively pressed after shock advisement
timeFrame: Up to 15 minutes during device placement
measure: Indicators of battery status/depletion (device logged data)
timeFrame: Up to 15 minutes during device placement
measure: Aborted shocks because of low or high impedance
timeFrame: Up to 15 minutes during device placement
measure: CPR guidance initiated (i-button pushed)
timeFrame: Up to 15 minutes during device placement
measure: CPR activity
timeFrame: Up to 15 minutes during device placement
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Philips
state: Pennsylvania
Study officials:
affiliation: Philips Healthcare
name: Gerrit Noordergraaf, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: