ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients

Study Overview
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Brief Summary
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This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD systems.

Detailed Description
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This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by demonstrating a low percentage of patients with false positive events.

Official Title
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ST Monitoring to Detect ACS Events in ICD Patients

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible patients will meet all of the following: Have an indication for an ICD implantation or pulse generator change Have documented coronary artery disease. Documented coronary artery disease is defined as having at least one of the following present a) evidence of a prior MI on ECG and/or cardiac enzymes, b) prior revascularization (by coronary artery bypass grafting or percutaneous coronary intervention) c) angina and/or ST-T wave abnormalities indicative of ischemia on exercise stress test, nuclear stress test, or echo stress test, or d) coronary artery disease diagnosed by coronary angiography. Willing and able to comply with protocol requirements, including keeping all required visits Willing to participate in the study and able to sign an IRB approved informed consent form Be at least 18 years of age when enrolled in the study Exclusion Criteria: Patients will be excluded if they meet any of the following: Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time) Have NYHA Class IV Heart Failure Have persistent or permanent atrial fibrillation Have a known history of intermittent Bundle Branch Block Pregnant or planning a pregnancy during the study participation Have a life expectancy of < 1 year due to any condition Are currently participating in a clinical investigation that includes an active treatment arm.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ST Monitoring Feature<br>ST segment continous monitoring feature enabled and programmed ON | Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices<br>* Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.<br>* Other names: ST Monitoring Feature;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Experience a False Positive ST Detection in 12 Months FU |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD Indicated patients, documented CAD