HeartStart FRx Defibrillator Event Registry (NCT04250857)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Philips — Monroeville, Pennsylvania
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Philips — Monroeville, Pennsylvania
📞 Contact the Study Coordinator
Phone: (724) 708-7048
Email: barb.fink@philips.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Sudden Cardiac Arrest
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- AI-guided Prediction and Treatment of Cardiac Arrest — Cleveland, Ohio
- HeartStart HS1 Defibrillator* Event Registry — Pittsburgh, Pennsylvania
- ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS) — Seattle, Washington
- HS Students Mandatory Universal Student Instruction in CPR Appraised Learning- Is the Mandate Working? — Overland Park, Kansas
Explore by condition: All Sudden Cardiac Arrest clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.