AngelMed Guardian® System Post-Approval Study for Acute Coronary Syndrome
This study is observing how well the AngelMed Guardian® System works in real-world use. This system is an implantable device that monitors your heart and alerts you if it detects signs of a heart attack (Acute Coronary Syndrome or ACS). You might be able to join if you are 21 or older, have had previous ACS events, and are at high risk for more, especially if you have diabetes, kidney problems, or a high TIMI Risk Score. The study aims to understand the device's accuracy in detecting ACS events and how doctors and patients use it. The study is ongoing and plans to enroll at least 500 patients.
- Study design
- This is an observational study, meaning researchers will watch how the AngelMed Guardian® System is used in at least 500 patients. It is a single-arm study, so all participants will receive the device.
- What's involved
- You will have an initial programming visit 7-14 days after the device is implanted, and then follow-up visits every 6 months until the study ends or you leave the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 3 years, or until 314 ACS events have been collected for the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
AngelMed Guardian® System PMA Post Approval Study
At a glance
Conditions
NCT05412927
Where you'd take part
This study runs at 18 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Arizona Heart & Vascular Clinic
Glendale, Arizonastudy coordinator listed
Recruiting
Clermont Ambulatory Surgical Center
Clermont, Floridastudy coordinator listed
Recruiting
Daytona Heart Group
Daytona Beach, Floridastudy coordinator listed
Recruiting
East Los Angeles Cardiology
Los Angeles, Californiastudy coordinator listed
Recruiting
Florida Heart Rhythm Specialists
Fort Lauderdale, Floridastudy coordinator listed
Recruiting
Heart Clinic of Hammond
Hammond, Louisianastudy coordinator listed
Recruiting
Institute for Cardiovascular Research Studies, Inc.
Miami, Floridastudy coordinator listed
Recruiting
Medical City Hospital Forth Worth
Fort Worth, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- David Keenan · STUDY_DIRECTOR · Angel Medical Systems Inc.
- Sasha John, PhD · STUDY_DIRECTOR · Angel Medical Systems Inc.
- Haroon Faraz, MD · PRINCIPAL_INVESTIGATOR · Hackensack-Meridian Health Care System
Who to contact
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Inclusion
Exclusion
What this trial measures
- Efficacy (PPV and FPR)The PAS is a 3 year, event based study, looking to accumulate 314 ACS events. Patients will be seen for an in-office initial programming visit 7-14 days following implant and every 6 months thereafter until study exit or study completion.
This study is a post approval study aiming to gather data from FDA approved and standard of care implants using the proprietary medical device created by Angel Medical Systems, The Guardian. The study is collecting specific information from the subjects, devices and index procedure to demonstrate non-inferior performance of a now FDA approved product in a commercial setting. The diagnostic accuracy of the device will be assessed by comparing the Positive Predictive Value (PPV) and the False Positive Rate (FPR) results in the PAS to the results for the same endpoints in the ALARMS-ON group in the PMA-Amendment (i.e. including patients who both had the device implanted and alarms turned on). The hypotheses will be assessed with performance goals for both PPV and FPR.