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Recruiting NCT04840797

HeartStart HS1 Defibrillator* Event Registry

— Observational Sudden Cardiac Arrest

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HeartStart HS1.
Who it may be relevant to
Registry conditions: Sudden Cardiac Arrest. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Device HeartStart HS1
    Automated External Defibrillator

Primary outcome measures

  • Mean shock energy delivered in the pediatric population [Time frame: Up to 15 minutes during device placement]
  • Mean shock energy delivered in the adult population [Time frame: Up to 15 minutes during device placement]
  • The Patient Analysis System (PAS) shock advisory algorithm performance as determined by evaluation of the ECG as aligned with the device advisement. [Time frame: Up to 15 minutes during device placement]
  • Accurate detection of shockable rhythms and facilitation of shocks. [Time frame: Up to 15 minutes during device placement]
  • Defibrillation success [Time frame: Up to 15 minutes during device placement]
Secondary outcome measures (12)
  • Frequency and severity of unexpected adverse events [Time frame: Up to 15 minutes during device placement]
  • Unanticipated adverse device effects (UADE) [Time frame: Up to 15 minutes during device placement]
  • Median operating time intervals [Time frame: Up to 15 minutes during device placement]
  • Routine self-test performance/Battery Insertion self-test performance [Time frame: Up to 15 minutes during device placement]
  • Device arming after shock advisement. [Time frame: Up to 15 minutes during device placement]
  • Energy delivered consistent with device labeling [Time frame: Up to 15 minutes during device placement]
  • Pad replacement notification [Time frame: Up to 15 minutes during device placement]
  • Shock button effectively pressed after shock advisement [Time frame: Up to 15 minutes during device placement]
  • Indicators of battery status/depletion (device logged data) [Time frame: Up to 15 minutes during device placement]
  • Aborted shocks because of low or high impedance [Time frame: Up to 15 minutes during device placement]
  • CPR guidance initiated (i-button pushed) [Time frame: Up to 15 minutes during device placement]
  • CPR activity [Time frame: Up to 15 minutes during device placement]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Philips — Pittsburgh

Identifiers

NCT: NCT04840797 · TC_ECR_HS1_2020_10819

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗