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

Abbott

Status

Terminated

Conditions

Coronary Artery Disease

Treatments

Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices

Study type

Interventional

Funder types

Industry

Identifiers

NCT01424722

CRD_420

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2,258 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Eligible patients will meet all of the following:
1. Have an indication for an ICD implantation or pulse generator change
2. 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.
3. Willing and able to comply with protocol requirements, including keeping all required visits
4. Willing to participate in the study and able to sign an IRB approved informed consent form
5. 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:
1. Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time)
2. Have NYHA Class IV Heart Failure
3. Have persistent or permanent atrial fibrillation
4. Have a known history of intermittent Bundle Branch Block
5. Pregnant or planning a pregnancy during the study participation
6. Have a life expectancy of < 1 year due to any condition
7. Are currently participating in a clinical investigation that includes an active treatment arm.