The AngelMed Guardian® System is a device to help doctors monitor patients with heart problems. The study involves at least 500 patients who have had heart issues before and are at high risk for more. The device works by giving alerts for emergencies or when it's time to see a doctor. Doctors will program the device in the office a week or two after it’s put in, and then check it every 6 months. The study will finish once they collect data from 314 heart events.
Key Points:
- Visits: Initial visit 7-14 days after device implant and every 6 months.
- Participants: Must have past heart issues; exclusions include certain medical conditions and other restrictions.
- Compensation: Not mentioned.
To join the study, you need to be over 21 and have a history of heart problems like diabetes or high-risk heart conditions. You can't join if you have certain health issues, like epilepsy or if you can't respond to alarms. The trial helps ensure the device and the training for doctors and patients work well.