HeartStart HS1 Defibrillator* Event Registry

Last updated: February 25, 2025
Sponsor: Philips Clinical & Medical Affairs Global
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Attack (Myocardial Infarction)

Cardiac Disease

Treatment

HeartStart HS1

Clinical Study ID

NCT04840797
TC_ECR_HS1_2020_10819
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 referencedPhilips electrode pads. Note: Use of a device other than the Philips HeartStart HS1AED does not preclude enrollment if the AED or an Advanced Life Supportdefibrillator was used after the HeartStart HS1 AED.

  • AED used for training purposes.

Study Design

Total Participants: 1400
Treatment Group(s): 1
Primary Treatment: HeartStart HS1
Phase:
Study Start date:
February 25, 2021
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Philips

    Pittsburgh, Pennsylvania 15206
    United States

    Active - Recruiting

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