CTRI/2011/08/001939
Not Applicable
Phase 2
ALERTS (AngeLmed for Early Recognition and Treatment of STEMI) Study - ALERTS
Angel Medical Systems Inc0 sites1,020 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Myocardial Infarction, Acute Coronary Syndrome
- Sponsor
- Angel Medical Systems Inc
- Enrollment
- 1020
- Status
- Not Applicable
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •All of the following criteria must be present:
- •1\.Subject has at least one of the following conditions:
- •a) Diabetes (Type I or Type II)
- •b) Compromised renal function (Cr 1\.2 mg/dl or creatinine clearance less than 50\)
- •c) TIMI Risk Score 3
- •2\.Presents (within past 6 months) 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 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:
Exclusion Criteria
- •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 patient 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), or Brugada Syndrome.
- •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\).
Outcomes
Primary Outcomes
Not specified
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