HeartStart FRx Defibrillator Event Registry

Part of paid clinical trials in Monroeville, Pennsylvania.

Sponsor
Philips Clinical & Medical Affairs Global
Study ID
NCT04250857
Status
Recruiting
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Conditions

  • Sudden Cardiac Arrest

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • HeartStart FRX — DEVICE
    Automated External Defibrillator

Study Details

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.

Key Dates

Start date
Nov 4, 2019
Status verified
Feb 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,400 participants (estimated)

Arms

  • Arm: Suspected Sudden Cardiac Arrest
    All subject with suspected of a circulatory arrest for any cause.

Primary Outcome Measure

Algorithm accuracy [ Time Frame: Up to 15 minutes after device placement ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PhilipsMonroevillePennsylvania15146
Barb Fink
[email protected]
724-708-7048
Gerrit Noordergraaf, MD (PRINCIPAL_INVESTIGATOR)

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