RecruitingAcute Coronary Syndrome
AngelMed Guardian® System PMA Post Approval Study
Eligible age
21+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Angel Medical Systems
You may qualify if…
- ✓ 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:
You may not qualify if…
- ✕ 1\. In the investigator's opinion, subject lacks ability to respond appropriately to alarms, e.g., illiteracy, poor memory or cognitive function, dementia or other condition affecting memory function, etc.
- ✕ 2\. There is known compromised tissue at the site of lead implantation in the apex of the right ventricle, e.g., prior infarct affecting the RV apex location.
- ✕ 3\. A permanent pacemaker or ICD is already in place or the subject is indicated for ICD or pacemaker implantation based on the guidelines published by the American College of Cardiology as Class I and IIa recommendations. Class IIb recommendations are at the investigator's discretion.
- ✕ 4\. Subject cannot feel the IMD vibration when placed on top of the skin on the left pectoral side of the chest.
- ✕ 5\. Subject has recurrent or persistent atrial fibrillation. 6. Subject has recurrent or persistent non-sinus cardiac rhythm, second or third degree atrioventricular blocks, QRS duration greater than 120 ms, Benign Early Repolarization (BER), Brugada Syndrome (LLB, BBB, RBB) or Rate Induced BBB.
- ✕ 7\. Subject has left ventricular hypertrophy evidenced by EKG criteria. 8. Subject has any condition preventing the subcutaneous implantation of the Guardian® System in a left pectoral pouch, such as: superior vena cava thrombosis, subcutaneous tissue deemed inappropriate for the procedure or prior central venous access via portacath, Hickman, Groshong, or similar placed in a left pectoral location or left side PICC line.
- ✕ 9\. Subject has extremely heavy alcohol consumption (participates in binge drinking that leads to alcohol intoxication) or has history of alcohol or illicit drug abuse within past 5 years.
- ✕ 10\. There is evidence of unresolved infection (fever \> 38o C and/or leukocytosis \> 15,000).
Where it's recruiting
Source: ClinicalTrials.gov · NCT05412927 · last updated 2025-09-30