Actively Recruiting
HeartStart FRx Defibrillator Event Registry
Led by Philips Clinical & Medical Affairs Global · Updated on 2025-02-26
1400
Participants Needed
1
Research Sites
421 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.
CONDITIONS
Official Title
HeartStart FRx Defibrillator Event Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected circulatory arrest for any cause
- 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 for training purposes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Philips
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
Research Team
B
Barb Fink
CONTACT
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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