Status:
RECRUITING
HeartStart HS1 Defibrillator* Event Registry
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Sudden Cardiac Arrest
Eligibility:
All Genders
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 Heart...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT04840797
Start Date
February 25 2021
End Date
December 1 2027
Last Update
February 26 2025
Active Locations (1)
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1
Philips
Pittsburgh, Pennsylvania, United States, 15206