Recruiting

HeartStart OnSite & HeartStart Home

Sponsor:

Heartstream US LLC

Code:

NCT04840797

Conditions

Sudden Cardiac Arrest

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

HeartStart HS1

Study Details

Brief summary:

A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data.

Conditions

Sudden Cardiac Arrest

Study ID

NCT04840797

Start date

Feb 25, 2021

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:

  • Have been suspected of a circulatory arrest for any cause.
  • Have had HeartStart HS1 Defibrillator with electrodes:

Adult SMART Pads Cartridge \[REF: M5071A\], Infant/Child SMART Pads Cartridge (REF:M5072A) applied to their body and powered up with HS1 battery (Model M5070A), regardless of whether a defibrillation shock was delivered

Exclusion Criteria:

  • Subjects will be excluded if any of the following are present:
  • AED or pad use other than the HeartStart HS1 Defibrillator with above referenced Philips electrode pads. Note: Use of a device other than the Philips HeartStart HS1 AED does not preclude enrollment if the AED or an Advanced Life Support defibrillator was used after the HeartStart HS1 AED.
  • AED used for training purposes.

Study Design

Enrollment

1400 participants

Anticipated

Interventions and Outcome Measures

Arms

Suspected Sudden Cardiac Arrest

All subjects with suspected of a circulatory arrest of any cause.

Interventions

HeartStart HS1

Automated External Defibrillator

Primary outcome measure

  • Mean shock energy delivered in the pediatric population [ Time Frame: Up to 15 minutes during device placement ]
  • Mean shock energy delivered in the adult population [ Time Frame: Up to 15 minutes during device placement ]
  • The Patient Analysis System (PAS) shock advisory algorithm performance as determined by evaluation of the ECG as aligned with the device advisement. [ Time Frame: Up to 15 minutes during device placement ]
  • Accurate detection of shockable rhythms and facilitation of shocks. [ Time Frame: Up to 15 minutes during device placement ]
  • Defibrillation success [ Time Frame: Up to 15 minutes during device placement ]

Central Contacts and Locations

Central contacts

Chase Wennick

617-398-7347chase.wennick@philips.com

Barbara Fink

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

Locations

Philips

Recruiting

Pittsburgh, Pennsylvania, United States, 15206

Contacts

Chase Wennick

617-398-7347chase.wennick@philips.com

Principal Investigator:

Gerrit Nordergraaf, MD PhD

More Information

Sponsor

Heartstream US LLC

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • AED
  • Post -Market
  • Cardiology

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.