RecruitingNCT04840797

HeartStart HS1 Defibrillator* Event Registry


Sponsor

Philips Clinical & Medical Affairs Global

Enrollment

1,400 participants

Start Date

Feb 25, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data.


Eligibility

Inclusion Criteria3

  • 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 Criteria3

  • 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.

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Interventions

DEVICEHeartStart HS1

Automated External Defibrillator


Locations(1)

Philips

Pittsburgh, Pennsylvania, United States

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NCT04840797


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