HeartStart HS1 Defibrillator* Event Registry

Sudden Cardiac Arrest Clinical Trial

Official title:

HeartStart HS1 Defibrillator* Event Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04840797
• Other study ID #: TC_ECR_HS1_2020_10819
• Status: Recruiting
• Start date: February 25, 2021
• Est. completion date: December 2027

Study information

• Verified date: September 2023
• Source: Philips Clinical & Medical Affairs Global
• Contact: Andrew Lee
• Phone: 412-542-3462
• Email: Andrew.Lee[@]philips.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Sudden Cardiac Arrest

Intervention

Device:
• HeartStart HS1
Automated External Defibrillator

Locations

Country	Name	City	State
United States	Philips	Pittsburgh	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	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
Primary	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
Secondary	Frequency and severity of unexpected adverse events	Frequency and severity of unexpected adverse events	Up to 15 minutes during device placement
Secondary	Unanticipated adverse device effects (UADE)	Unanticipated adverse device effects (UADE)	Up to 15 minutes during device placement
Secondary	Median operating time intervals	Median operating time intervals	Up to 15 minutes during device placement
Secondary	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