CHAMP App Cardiac Study and Repository

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.