AngelMed Guardian® System PMA Post Approval Study

Recruiting Observational Study
Acute Coronary Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
21 and older
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
Angel Medical Systems · Industry
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About This Trial

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.

Trial Locations
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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…
Contacts

Jacqueline Finley, BS

732.542.5551

jfinley@avertix.com

CONTACT

Sasha John, PhD

6466444661

sjohn@avertix.com

CONTACT