Actively Recruiting
HeartStart HS1 Defibrillator Event Registry Monitoring Safety and Performance in Suspected Sudden Cardiac Arrest
Led by Philips Clinical & Medical Affairs Global · Updated on 2025-02-26
1400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the HeartStart HS1 Defibrillator, including the HeartStart OnSite and Home models, in people suspected of circulatory arrest. This observational post-market study collects data on how well the device works according to its commercial labeling and how different types of electrode pads affect its function. Participants suspected of sudden cardiac arrest will have the HeartStart HS1 Defibrillator used with specific Philips electrode pads applied to their body and powered by the HS1 battery. The study observes the device's energy delivery, shock advisory algorithm accuracy, detection of shockable rhythms, defibrillation success, and other device functions during the first 15 minutes of device placement. During the study, data is collected on shock energy delivered, device self-tests, battery status, CPR guidance activation, and any unexpected adverse events. Researchers monitor device performance and patient outcomes up to 15 minutes after device use. The study includes all ages and both genders, and participation involves observation and recording of device use during suspected cardiac arrest events.
CONDITIONS
Brief Title
HeartStart HS1 Defibrillator* Event Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected of circulatory arrest for any cause
- Had HeartStart HS1 Defibrillator applied with Adult SMART Pads Cartridge or Infant/Child SMART Pads Cartridge
- Device was powered by HS1 battery (Model M5070A)
- Included regardless of whether a defibrillation shock was delivered
You will not qualify if you...
- Use of AED or pads other than HeartStart HS1 Defibrillator with specified Philips electrode pads
- AED used solely for training purposes
- Use of a device other than Philips HeartStart HS1 AED before an Advanced Life Support defibrillator does not exclude enrollment if HeartStart HS1 AED was used first or during event
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during which eligibility is confirmed based on suspected circulatory arrest and device application
Duration - Up to 15 minutes during device placement
Participants who have the HeartStart HS1 Defibrillator applied during suspected circulatory arrest are observed for device safety and performance.
Continuous monitoring during the event with no additional visits required
Trial Site Locations
Total: 1 location
1
Philips
Pittsburgh, Pennsylvania, United States, 15206
Actively Recruiting
Research Team
C
Chase Wennick
B
Barbara Fink
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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