HeartStart FRx Defibrillator Event Registry

Last updated: February 25, 2025
Sponsor: Philips Clinical & Medical Affairs Global
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Attack (Myocardial Infarction)

Cardiac Disease

Treatment

HeartStart FRX

Clinical Study ID

NCT04250857
MATC-ECR-Registry-2018-10295
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects accepted into the study must: have been suspected of a circulatory arrestfor any cause

  • Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied totheir body and powered up, regardless of whether a defibrillation shock wasdelivered

Exclusion

Exclusion Criteria:

  • AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMARTPADS II

  • AED used for training purposes.

Study Design

Total Participants: 1400
Treatment Group(s): 1
Primary Treatment: HeartStart FRX
Phase:
Study Start date:
November 04, 2019
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Philips

    Monroeville, Pennsylvania 15146
    United States

    Active - Recruiting

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