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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: Recruiting study of Sudden Cardiac Arrest, sponsored by Philips Clinical & Medical Affairs Global.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.
Conditions Studied
Interventions
- DEVICE HeartStart FRX
Study Locations (1)
Pennsylvania
- Philips - Monroeville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,400 participants |
| Start Date | 2019-11-04 |
| Est. Completion | 2027-12 |
What NCT04250857 shows while recruiting
NCT04250857 is an observational study that tracks outcomes without assigning an intervention. Its 1,400 participants enrollment target places it among the larger protocols in the corpus, below the 1,660-participant average among 8 other Sudden Cardiac Arrest trials with a reported enrollment target (16% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04250857's enrollment target sits among peer trials
1,400 3rd of 8 higher than 5 of 8 other Sudden Cardiac Arrest trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sudden Cardiac Arrest trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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