NCT05412927

AngelMed Guardian® System PMA Post Approval Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Angel Medical Systems · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

500 Patients (minimum) will be enrolled following commercial implant. Will be treated by their physicians using the standard of care. Standard of care for the Guardian includes an in-office initial programming visit 7-14 days following implant and every 6 months.

Detailed description

The purpose of this prospective, non-randomized, single arm, event-based, multicenter trial is to assess: (1) the diagnostic accuracy of the device, (2) the compliance of the prescribing physician, (3) the experience of the implanting physician, (4) the experience of the emergency department physician and (5) the patient compliance for "Emergency" and "See Doctor" alerts. The adequacy of the training program for the prescribing physician, implanting physician, emergency department physician, and patients will be assessed. A minimum of 500 patients who have had prior ACS events and who remain at high risk for recurrent ACS events will be enrolled in the PAS, for the purpose of accruing 314 adjudicated True Positive (TP) or False Positive (FP) ACS events. These ACS events will contribute to the Positive Predictive Value (PPV) and false positive rate (FPR) endpoints of the study. The PAS will be completed once the 314 ACS events have been collected and adjudicated.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	PMA P150009 AngelMed Guardian® System	The AngelMed Guardian® System is an implantable cardiac monitor with patient alerting capability and an additional external alarm device. The Guardian® System is indicated for use in patients who have had prior ACS events and who remain at high risk for recurrent ACS events. The Guardian® System is indicated as an adjunct to patient recognized symptoms. The Guardian® System detects potential ongoing ACS events, characterized by sustained ST segment changes, and alerts the patient to seek medical attention for those potential ACS events. A Guardian® System alert is a more accurate predictor of ACS events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without ACS events (false positives) when compared to patient recognized symptoms alone. In the absence of symptoms, the Guardian® System may identify asymptomatic ACS events and prompt the patient to seek medical attention.

Timeline

• Start date: 2022-09-07
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-06-09
• Last updated: 2025-09-30

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study