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CHAMP App Cardiac Study and Repository

NCT06034392 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-05-07

No results posted yet for this study

Summary

This is a multi-site research study with an optional research repository that will consist of clinically derived data and photographic or video images of patients in the home setting with complex health conditions to evaluate the safety and efficacy of the CHAMP® software platform, with data and photographic or video images input and/or uploaded by the parent or other legally authorized representative (LAR) of patients with complex congenital heart disease as a target population.

Conditions

  • Heart Defects, Congenital
  • Pediatrics

Interventions

DEVICE

CHAMP App

CHAMP® App is a downloadable software mobile Application with a Software Platform. CHAMP® App is an electronic version of data entry for children with conditions that require close monitoring from their homes. The primary Intended Use is to relay monitoring information from homes to the health care team. This monitoring includes data options that can facilitate the collection of monitoring data of children in the home setting to improve communications between parents at home and remote caregivers. The CHAMP® App itself does not do home monitoring of the child's medical condition. It is not designed to alert parents if data entered has reached a red flag (problem) level. Users of the CHAMP App are advised in writing and in the informed consent process that urgent medical conditions should not be managed through the CHAMP App, and that appropriate emergency care should be obtained directly rather than through the CHAMP App.

Sponsors & Collaborators

  • Lori Erickson

    lead OTHER

Principal Investigators

  • Lori Erickson, PhD · Director, Remote Health Solutions Children's Mercy

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06034392 on ClinicalTrials.gov