HeartStart HS1 Defibrillator* Event Registry

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

Study Overview

• Status: Recruiting
• Conditions: Sudden Cardiac Arrest
• Intervention / Treatment: Device: HeartStart HS1

Detailed Description

The objective of this PMCF (Post Market Clinical Follow-up) prospective collection of post-event data registry is to confirm the safety and performance as expressed in the energy delivery by the HeartStart HS1 Defibrillator (HeartStart OnSite and Home models in North America) in the population for the device's intended use in reference to its commercial labeling, and in relationship to the type of pads attached to the device.

• Study Type: Observational
• Enrollment (Estimated): 1400

Contacts and Locations

• Study Contact: Name: Barbara Fink; Phone Number: 724-708-7048; Email: barb.fink@philips.com
• Study Contact Backup: Name: Chase Wennick; Phone Number: 617-398-7347; Email: chase.wennick@philips.com

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15206
      • Recruiting
      • Philips
      • Principal Investigator: Gerrit Nordergraaf, MD PhD
      • Contact: Chase Wennick; Phone Number: 617-398-7347; Email: chase.wennick@philips.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Anyone who is suspected of having a sudden cardiac arrest.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected Sudden Cardiac Arrest; All subjects with suspected of a circulatory arrest of any cause.	Device: HeartStart HS1; Automated External Defibrillator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of unexpected adverse events	Frequency and severity of unexpected adverse events	Up to 15 minutes during device placement
Unanticipated adverse device effects (UADE)	Unanticipated adverse device effects (UADE)	Up to 15 minutes during device placement
Median operating time intervals	Median operating time intervals	Up to 15 minutes during device placement
Routine self-test performance/Battery Insertion self-test performance	Routine self-test performance/Battery Insertion self-test performance	Up to 15 minutes during device placement
Device arming after shock advisement.	The percentage of events where the device advised a shock and the device armed.	Up to 15 minutes during device placement
Energy delivered consistent with device labeling	The percentage of defibrillations in which the energy delivered was consistent with device labeling.	Up to 15 minutes during device placement
Pad replacement notification	Number of events in which pads were replaced at any time during the event after the user is prompted to do so by the device	Up to 15 minutes during device placement
Shock button effectively pressed after shock advisement	The percentage of events where a shock was recommended by the device and the shock button was pressed.	Up to 15 minutes during device placement
Indicators of battery status/depletion (device logged data)	Percentage of events that include indicators of battery status/depletion (device logged data)	Up to 15 minutes during device placement
Aborted shocks because of low or high impedance	Percentage of aborted shocks because of low or high impedance	Up to 15 minutes during device placement
CPR guidance initiated (i-button pushed)	Percentage of events where CPR guidance was initiated (i-button pushed)	Up to 15 minutes during device placement
CPR activity	Percentage of events where CPR is performed during CPR guidance	Up to 15 minutes during device placement

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: Gerrit Noordergraaf, MD PhD, Philips Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: AED; Cardiology; Post -Market
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Death; Heart Arrest; Death, Sudden; Death, Sudden, Cardiac
• Other Study ID Numbers: TC_ECR_HS1_2020_10819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No