HeartStart FRx Defibrillator Event Registry

Philips

Status: Enrolling

Conditions: Sudden Cardiac Arrest

Treatments: Device: HeartStart FRX

Study type: Observational

Funder types: Industry

Identifiers

NCT04250857

MATC-ECR-Registry-2018-10295

Details and patient eligibility

About

This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.

Enrollment: 1,400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause
• Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered

Exclusion criteria

• AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
• AED used for training purposes.

Trial design

1,400 participants in 1 patient group

Suspected Sudden Cardiac Arrest

Description:

All subject with suspected of a circulatory arrest for any cause.

Treatment:

Device: HeartStart FRX