HeartStart HS1 Defibrillator* Event Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-25

Study Completion Date

2027-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sudden Cardiac Arrest

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected Sudden Cardiac Arrest

All subjects with suspected of a circulatory arrest of any cause.

HeartStart HS1

Intervention Type DEVICE

Automated External Defibrillator

Interventions

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HeartStart HS1

Automated External Defibrillator

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No