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AngelMed Guardian® System PMA Post Approval Study

NCT05412927 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome

Interventions

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.

Sponsors & Collaborators

  • Angel Medical Systems

    lead INDUSTRY

Principal Investigators

  • David Keenan · Angel Medical Systems Inc.

  • Sasha John, PhD · Angel Medical Systems Inc.

  • Haroon Faraz, MD · Hackensack-Meridian Health Care System

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-07
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 NCT05412927 on ClinicalTrials.gov