Status:
TERMINATED
ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 F...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
2258 Patients enrolled
Trial Details
Trial ID
NCT01424722
Start Date
August 1 2011
End Date
June 1 2017
Last Update
January 28 2021
Active Locations (97)
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1
Cardiovascular Associates PC
Birmingham, Alabama, United States, 35209
2
Cardiovascular Associates PC
Birmingham, Alabama, United States, 35213
3
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35233
4
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801