Recruiting

HeartStart FRx

Sponsor:

Heartstream US LLC

Code:

NCT04250857

Conditions

Sudden Cardiac Arrest

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

HeartStart FRX

Study Details

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

Study ID

NCT04250857

Start date

Nov 4, 2019

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

1400 participants

Anticipated

Interventions and Outcome Measures

Arms

Suspected Sudden Cardiac Arrest

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

Interventions

HeartStart FRX

Automated External Defibrillator

Primary outcome measure

  • Algorithm accuracy [ Time Frame: Up to 15 minutes after device placement ]
  • Shock Delivery [ Time Frame: 1 day ]
  • Unexpected adverse events. [ Time Frame: 1 day ]
  • Unanticipated adverse device effects (UADE) [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Barb Fink

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

Locations

Philips

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Barb Fink

7247087048barb.fink@philips.com

Principal Investigator:

Gerrit Noordergraaf, MD

More Information

Sponsor

Heartstream US LLC

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Heartstream US LLC on 2026-08-11.