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AngelMed for Early Recognition and Treatment of STEMI

This study is currently Recruiting

May 2011 By Angel Medical Systems

First Recieved on October 24, 2008

Last Updated on May 6, 2011

Sponsor: Angel Medical Systems
Collaborators: Symbios Clinical
Information provided by: Angel Medical Systems
Identifier: NCT00781118


A prospective, randomized multicenter study of subjects with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Ages Eligible for Study:21 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Inclusion Criteria: - 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 ? 3 - 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. - Has already undergone coronary angiography and revascularization, unless the physician determines it is appropriate to implant before or during the planned procedure. - Lives in a geographic area in close proximity (within 60 minutes by EMS) to any hospital that can treat AMI. - 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 amenorrheic during the past year 2. Surgical sterilization 3. Use of effective contraceptive method Exclusion Criteria: - 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. - 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. - 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. - Subject cannot feel the IMD vibration when placed on top of the skin on the left pectoral side of the chest. - Subject has recurrent or persistent atrial fibrillation. - 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. - Subject has left ventricular hypertrophy evidenced by EKG criteria. - 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. - 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. - There is evidence of unresolved infection (fever > 38? C and/or leukocytosis > 15,000). - Subject has history of bleeding disorders or severe coagulopathy (platelets < 100,000 plts/ml; APTT or PT > 1.3 x reference range). - Subject has had a hemorrhagic stroke or transient ischemic attack (TIA) in the past 6 months. - Subject has other severe diseases, such as cancer or refractory congestive heart failure, associated with limitation of life expectancy (less than 1 year), which may lead to inadequate compliance to the protocol or confusing data interpretation. - Subject has clinical conditions such as heart diseases, difficult-to-control blood pressure, difficult-to-control insulin-dependent diabetes or serious prior infections attributed to the diabetes, or others that, at the investigator's discretion, could seriously affect the subject's current clinical condition during study procedures. - Subject has previous participation in the DETECT Study, current participation or previous participation in another drug or device study in the past 30 days that conflicts with this study as determined by the study sponsor. - Subject has experienced gastro-intestinal hemorrhage in the past 6 months. - Subject has any situation in which the use of aspirin is contraindicated for at least 6 months. - Subject has epilepsy. - Subject has known severe allergies, e.g., peanut, bee sting, etc.



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