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NCT04250857 · ClinicalTrials.gov registry record

HeartStart FRx Defibrillator Event Registry

A clinical trial of Sudden Cardiac Arrest, sponsored by Philips Clinical & Medical Affairs Global.

Recruiting
Registry status
1,400
Enrollment target
1
Study location

NCT04250857 is a study of Sudden Cardiac Arrest that is actively recruiting participants, run by Philips Clinical & Medical Affairs Global. The registered enrollment target is 1,400 participants, below the 1,660-participant average among 8 other Sudden Cardiac Arrest trials with a reported enrollment target (16% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04250857, a study of Sudden Cardiac Arrest, is actively recruiting participants, sponsored by Philips Clinical & Medical Affairs Global.

RECRUITING
Registry status
1,400 participants
Enrollment target
1
Study location

Study 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 Studied

Sudden Cardiac Arrest

Interventions

  • DEVICE HeartStart FRX

Study Locations (1)

Pennsylvania

  • Philips - Monroeville

Trial Details

FieldValue
Enrollment Target 1,400 participants
Start Date 2019-11-04
Est. Completion 2027-12

Sponsor

Philips Clinical & Medical Affairs Global

45 total trials

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What the Registry Record Tells You About NCT04250857

The ClinicalTrials.gov registry entry for NCT04250857 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,660-participant average among 8 other Sudden Cardiac Arrest trials with a reported enrollment target (16% lower). The listed sponsor is Philips Clinical & Medical Affairs Global, which has 45 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sudden Cardiac Arrest appearing as the primary indexed condition, and to 1 intervention - of which HeartStart FRX is the first listed.

NCT04250857 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04250857 about?

NCT04250857 is a clinical study titled "HeartStart FRx Defibrillator Event Registry". 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...

What is the current status of trial NCT04250857?

This trial is currently recruiting. The enrollment target is 1,400 participants. The study started on 2019-11-04. Estimated completion is 2027-12.

What conditions does trial NCT04250857 study?

This clinical trial studies the following conditions: Sudden Cardiac Arrest.

What interventions are being tested in trial NCT04250857?

The interventions under investigation include: HeartStart FRX (DEVICE).

Who is sponsoring clinical trial NCT04250857?

This trial is sponsored by Philips Clinical & Medical Affairs Global, which has 45 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04250857 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.