ST Segment Detection Study

ST Segment Detection Study

The purpose of ST Detect study is to evaluate whether naturally occurring spontaneous coronary events and exercise induced cardiac ischemia, give rise to detectable changes on intracardiac electrogram (EGM) signals in patients that are indicated for an Implantable Cardioverter Defibrillator (ICD) who have coronary artery disease.

Inclusion Criteria:

• Subject is indicated for an ICD implantation

• AND subject must meet ONE of the following:

  • Prior acute coronary event
  • Previously underwent Percutaneous Coronary Intervention (PCI) or stent procedure
  • Multivessel disease
  • Positive stress test completed with evidence of ischemic heart disease, as determined by physician, and no subsequent successful revascularization

Exclusion Criteria:

• Subject is currently dependent on ventricular pacing
• Subject has Left Bundle Brunch Block (LBBB) and/or wide QRS
• Subject has chronic Atrial Fibrillation (AF)
• Subject has dementia
• Subject is indicated for a single chamber device
• Subject requires a right sided or abdominal ICD implant
• Subject is pregnant or in fertile age without secure birth control
• Subject has New York Heart Association (NYHA) class IV or refractory heart failure
• Subject is not expected to survive greater than 12 months
• Subject is participating in other confounding research studies