HeartStart HS1 Defibrillator* Event Registry

NCT04840797 | Recruiting FDA Device

• 1 other identifier: TC_ECR_HS1_2020_10819
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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

Keywords

AED; Post -Market; Cardiology

Outcome Measures

Primary Outcomes (5)

• Mean shock energy delivered in the pediatric population

  Mean of shock energy delivered, when the pediatric defibrillation pads were attached to the AED as intended for infants and children under 25 kilograms / 55 pounds or 0-8 years old.

  Up to 15 minutes during device placement

• Mean shock energy delivered in the adult population

  Mean of shock energy delivered, when the adult defibrillation pads were attached to the AED as intended for in children and adults over 25 kilograms / 55 pounds or greater than 8 years old.

  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.

  Performance is defined by the sensitivity and specificity; positive predictive value and false positive rate will be reported for each rhythm category (as defined by device labeling).

  Up to 15 minutes during device placement

• Accurate detection of shockable rhythms and facilitation of shocks.

  The percentage of events where a shockable rhythm was identified by the device, the device advised a shock, and the device delivered a shock when the shock button was pressed.

  Up to 15 minutes during device placement

• Defibrillation success

  Defibrillation success and the number of shocks required for success.

  Up to 15 minutes during device placement

Secondary Outcomes (12)

• Frequency and severity of unexpected adverse events

  Up to 15 minutes during device placement

• Unanticipated adverse device effects (UADE)

  Up to 15 minutes during device placement

• Median operating time intervals

  Up to 15 minutes during device placement

• Routine self-test performance/Battery Insertion self-test performance

  Up to 15 minutes during device placement

• Device arming after shock advisement.

  Up to 15 minutes during device placement

Study Arms (1)

Suspected Sudden Cardiac Arrest

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

Device: HeartStart HS1

Interventions

HeartStart HS1 DEVICE

Automated External Defibrillator

Suspected Sudden Cardiac Arrest

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anyone who is suspected of having a sudden cardiac arrest.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Philips

Pittsburgh, Pennsylvania, 15206, United States

RECRUITING

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerrit Noordergraaf, MD PhD

  Philips Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chase Wennick

CONTACT

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

Barbara Fink

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: February 25, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)