NCT04250857

HeartStart FRx Defibrillator Event Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,400 (estimated)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

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

• Sudden Cardiac Arrest

Interventions

Type	Name	Description
DEVICE	HeartStart FRX	Automated External Defibrillator

Timeline

• Start date: 2019-11-04
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2020-01-31
• Last updated: 2025-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study