Actively Recruiting
HeartStart FRx Defibrillator Event Registry Observational Study in 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
This research aims to collect real-world data on the HeartStart FRx Automated External Defibrillator (AED) performance in people suspected of sudden cardiac arrest from any cause. The study is an observational registry that tracks the device's use after an event, focusing on safety and verifying how well the device works according to its official claims. It is a multi-center study that does not influence how the device is used but ensures all participants who had the device pads placed are included to avoid selection bias. Participants in this registry have the HeartStart FRx AED with HeartStart SMART PADS II electrodes applied to their body and powered on, whether or not a shock was delivered. There is no randomization or treatment assignment as this is an observational study. The registry collects detailed information related to the device's algorithm accuracy within 15 minutes of placement, shock delivery, and any unexpected or unanticipated adverse events within one day of use. During the study, data collectors gather information on timing intervals, device preparation, shock energy delivered, pad replacement, and user details within one day after the event. The study monitors safety and device performance without altering usual care. Participation involves post-event data collection only, and the study will continue through to December 2027.
CONDITIONS
Brief Title
HeartStart FRx Defibrillator Event Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected of circulatory arrest for any cause
- Had HeartStart FRx AED with HeartStart SMART PADS II electrodes applied and powered on, regardless of shock delivery
You will not qualify if you...
- Use of AED or pads other than HeartStart FRx AED with HeartStart SMART PADS II
- AED used only for training purposes
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 or remote)
Duration - Up to 15 minutes after device placement
Participants who have a suspected circulatory arrest are observed when the HeartStart FRx defibrillator is applied and used.
Single event observation
Duration - 1 day
Participants are monitored for device performance and any adverse events following the use of the HeartStart FRx defibrillator.
1 follow-up visit within 1 day
Trial Site Locations
Total: 1 location
1
Philips
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
B
Barb 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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