HeartStart HS1 Defibrillator* Event Registry

Philips

Status: Enrolling

Conditions: Sudden Cardiac Arrest

Treatments: Device: HeartStart HS1

Study type: Observational

Funder types: Industry

Identifiers

NCT04840797

TC_ECR_HS1_2020_10819

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1,400 participants in 1 patient group

Suspected Sudden Cardiac Arrest

Description:

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

Treatment:

Device: HeartStart HS1