HeartStart FRx Defibrillator Event Registry

Sudden Cardiac Arrest Clinical Trial

Official title:

HeartStart FRx Defibrillator Event Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04250857
• Other study ID #: MATC-ECR-Registry-2018-10295
• Status: Recruiting
• Start date: November 4, 2019
• Est. completion date: December 2027

Study information

• Verified date: September 2023
• Source: Philips Clinical & Medical Affairs Global
• Contact: Barb Fink
• Phone: 724-708-7048
• Email: barb.fink[@]philips.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Sudden Cardiac Arrest

Intervention

Device:
• HeartStart FRX
Automated External Defibrillator

Locations

Country	Name	City	State
United States	Philips	Monroeville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Shock Delivery	Percentage of events where a shock was delivered when indicated.	1 day
Primary	Unexpected adverse events.	Frequency and severity of unexpected adverse events.	1 day
Primary	Unanticipated adverse device effects (UADE)	Unanticipated adverse device effects (UADE)	1 day
Secondary	Time Intervals	Measurements of device performance time intervals.	1 day
Secondary	Device Preparation	Percentage of events where the device prepared to shock.	1 day
Secondary	Shock Energy Delivered	The amount of shock energy delivered as measured in joules with each shock.	1 day
Secondary	Pad Replacement	Frequency of pad replacement.	1 day
Secondary	User	Frequency of user pressing the shock button.	1 day