HeartStart FRx Defibrillator Event Registry

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
View:

• 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

Locations
United States
Pennsylvania
Philips
RECRUITING
Monroeville
Contact Information
Primary
Barb Fink
barb.fink@philips.com
724-708-7048
Time Frame
Start Date: 2019-11-04
Estimated Completion Date: 2027-12
Participants
Target number of participants: 1400
Treatments
Suspected Sudden Cardiac Arrest
All subject with suspected of a circulatory arrest for any cause.
Related Therapeutic Areas
Sponsors
Leads: Philips Clinical & Medical Affairs Global

This content was sourced from clinicaltrials.gov