Registry for HeartStart HS1 Defibrillator performance and safety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects post-event data on the HeartStart HS1 Defibrillator to evaluate its safety and performance in real-world scenarios. It focuses on individuals who have experienced a suspected circulatory arrest and have had the HeartStart HS1 device applied. The study aims to confirm the effectiveness of the device as per its commercial labeling and assess the impact of different electrode pads used with the defibrillator. Data will be gathered prospectively to ensure comprehensive analysis of outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Philips
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Gerrit Noordergraaf, MD PhD — Philips Healthcare
• Study coordinator: Chase Wennick
• Email: chase.wennick@philips.com
• Phone: 617-398-7347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.