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Recruiting NCT05412927

AngelMed Guardian® System PMA Post Approval Study

Trial Parameters

Condition Acute Coronary Syndrome
Sponsor Angel Medical Systems
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2022-09-07
Completion 2026-12
Interventions
PMA P150009 AngelMed Guardian® System

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 1\. Subject has at least one of the following conditions: 1. Diabetes (Type I or Type II) 2. Compromised renal function (Cr \> 1.2 mg/dl or creatinine clearance less than 50) 3. TIMI Risk Score of at least 3 2\. Previously diagnosed with a high-risk acute coronary syndrome (e.g., Unstable Angina, STEMI or NSTEMI) or has undergone or is scheduled for CABG within 6 months of implantation. 3\. Has already undergone coronary angiography and revascularization, unless the physician determines it is appropriate to implant before or during the planned procedure. 4\. Lives in a geographic area in close proximity (within approximately 60 minutes by EMS) to any hospital that can treat AMI. 5\. Subjects (men or women) at least 21 years of age. Women of childbearing age must have a negative pregnancy test or confirmation of one of the following: <!-- --> 1. Post-menopause or amenorrhoeic during the past year 2. Surgical sterilization 3. Use of effective contraceptive method Ex

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