The AngelMed Guardian® System study is a research project to test a special device that helps doctors monitor heart health. It involves at least 500 patients who have had heart problems before and are at risk of having them again. The study looks at how well the device works, how doctors use it, and if patients follow its alerts. Here are some key points to know:
- Study Visits: After getting the device, patients see their doctor for a check-up 7-14 days later and then every 6 months.
- Enrollment Requirements: Participants need to meet certain health conditions and live close to a hospital.
- Risks: The study checks for possible issues like device alerts and other health conditions.
People who are 21 years or older, have certain health conditions like diabetes or heart problems, and live near a hospital can join this study. However, those with serious health issues, certain heart devices, or other conditions might not be eligible. This study helps determine if the device can accurately alert patients about heart problems in time for them to get help. Participants will receive care according to their doctor’s standard practices.