HeartStart FRx Defibrillator Event Registry

NCT04250857 | Recruiting FDA Device

• 1 other identifier: MATC-ECR-Registry-2018-10295
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Algorithm accuracy

  Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.

  Up to 15 minutes after device placement

• Shock Delivery

  Percentage of events where a shock was delivered when indicated.

  1 day

• Unexpected adverse events.

  Frequency and severity of unexpected adverse events.

  1 day

• Unanticipated adverse device effects (UADE)

  Unanticipated adverse device effects (UADE)

  1 day

Secondary Outcomes (5)

• Time Intervals

  1 day

• Device Preparation

  1 day

• Shock Energy Delivered

  1 day

• Pad Replacement

  1 day

• User

  1 day

Study Arms (1)

Suspected Sudden Cardiac Arrest

All subject with suspected of a circulatory arrest for any cause.

Device: HeartStart FRX

Interventions

HeartStart FRX DEVICE

Automated External Defibrillator

Suspected Sudden Cardiac Arrest

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Use of the HeartStart FRx AED is intended for the following populations in addition to adults: newborns, neonates, infant, children, and adolescents. It may also be used on pregnant women. Devices are located in public access spaces and with first responders around the world.

You may qualify if:

• Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause
• Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered

You may not qualify if:

• AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
• AED used for training purposes.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Philips

Monroeville, Pennsylvania, 15146, United States

RECRUITING

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Barb Fink

CONTACT

724-708-7048; barb.fink@philips.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 31, 2020
• Study Start: November 4, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)