HeartStart FRx Defibrillator Event Registry

Recruiting

• Conditions: Sudden Cardiac Arrest
• Interventions: Device: HeartStart FRX

• Registration Number: NCT04250857
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected Sudden Cardiac Arrest	HeartStart FRX	All subject with suspected of a circulatory arrest for any cause.

Primary Outcome Measures

Name	Time	Method
Unexpected adverse events.	1 day	Frequency and severity of unexpected adverse events.
Unanticipated adverse device effects (UADE)	1 day	Unanticipated adverse device effects (UADE)
Algorithm accuracy	Up to 15 minutes after device placement	Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement.
Shock Delivery	1 day	Percentage of events where a shock was delivered when indicated.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Philips; 🇺🇸 Monroeville, Pennsylvania, United States