RECRUITING

HeartStart FRx Defibrillator Event Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

HeartStart FRx Defibrillator Event Registry

Quick Facts

Study Start:2019-11-04
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04250857

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause
  2. * 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
  1. * AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II
  2. * AED used for training purposes.

Contacts and Locations

Study Contact

Barb Fink
CONTACT
724-708-7048
barb.fink@philips.com

Study Locations (Sites)

Philips
Monroeville, Pennsylvania, 15146
United States

Collaborators and Investigators

Sponsor: Philips Clinical & Medical Affairs Global

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-04
Study Completion Date2027-12

Study Record Updates

Study Start Date2019-11-04
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Sudden Cardiac Arrest