|Ages Eligible for Study:||21 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
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
- 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
- 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 >
- 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
- 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
- Subject has epilepsy.
- Subject has known severe allergies, e.g., peanut, bee sting, etc.