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-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.

Study Overview

• Status: Recruiting
• Conditions: Sudden Cardiac Arrest
• Intervention / Treatment: Device: HeartStart FRX

• Study Type: Observational
• Enrollment (Estimated): 1400

Contacts and Locations

• Study Contact: Name: Barb Fink; Phone Number: 724-708-7048; Email: barb.fink@philips.com

Study Locations

• United States
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • Recruiting
      • Philips
      • Contact: Barb Fink; Phone Number: 724-708-7048; Email: barb.fink@philips.com
      • Principal Investigator: Gerrit Noordergraaf, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected Sudden Cardiac Arrest; All subject with suspected of a circulatory arrest for any cause.	Device: HeartStart FRX; Automated External Defibrillator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Intervals	Measurements of device performance time intervals.	1 day
Device Preparation	Percentage of events where the device prepared to shock.	1 day
Shock Energy Delivered	The amount of shock energy delivered as measured in joules with each shock.	1 day
Pad Replacement	Frequency of pad replacement.	1 day
User	Frequency of user pressing the shock button.	1 day

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Heart Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: MATC-ECR-Registry-2018-10295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes