ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
Launched by ABBOTT MEDICAL DEVICES · Aug 26, 2011
Trial Information
Current as of August 02, 2025
Terminated
Keywords
ClinConnect Summary
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...
Gender
ALL
Eligibility criteria
- 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.
About Abbott Medical Devices
Abbott Medical Devices is a leading global healthcare company dedicated to advancing medical technology through innovative research and development. With a robust portfolio of diagnostic, therapeutic, and monitoring solutions, Abbott is committed to improving patient outcomes and enhancing the quality of care across various medical fields. The company places a strong emphasis on clinical trials to validate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals. By leveraging cutting-edge science and technology, Abbott Medical Devices aims to address pressing health challenges and deliver transformative solutions that empower patients and healthcare providers alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Cleveland, Ohio, United States
Lexington, Kentucky, United States
Traverse City, Michigan, United States
Pittsburgh, Pennsylvania, United States
Spartanburg, South Carolina, United States
Norfolk, Virginia, United States
Washington, District Of Columbia, United States
Winston Salem, North Carolina, United States
Temple, Texas, United States
Orlando, Florida, United States
Honolulu, Hawaii, United States
Fort Lauderdale, Florida, United States
Pittsburgh, Pennsylvania, United States
Louisville, Kentucky, United States
Cleveland, Ohio, United States
Browns Mills, New Jersey, United States
Newark, Delaware, United States
Haddon Heights, New Jersey, United States
Daytona Beach, Florida, United States
Southfield, Michigan, United States
Tyler, Texas, United States
Albuquerque, New Mexico, United States
Greensboro, North Carolina, United States
Los Angeles, California, United States
Ocala, Florida, United States
Elyria, Ohio, United States
Nashville, Tennessee, United States
Los Angeles, California, United States
Little Rock, Arkansas, United States
Glendale, California, United States
Memphis, Tennessee, United States
Rockville, Maryland, United States
Englewood, New Jersey, United States
Toledo, Ohio, United States
Bradenton, Florida, United States
Sacramento, California, United States
West Des Moines, Iowa, United States
New Orleans, Louisiana, United States
Long Beach, California, United States
Gainesville, Georgia, United States
Stony Brook, New York, United States
Greenville, South Carolina, United States
Columbus, Ohio, United States
Fort Wayne, Indiana, United States
Huntsville, Alabama, United States
Ashland, Kentucky, United States
La Jolla, California, United States
Rome, Georgia, United States
Concord, California, United States
Miami, Florida, United States
Tulsa, Oklahoma, United States
Little Rock, Arkansas, United States
Lansing, Michigan, United States
Mesa, Arizona, United States
Hammond, Louisiana, United States
Nashville, Tennessee, United States
Columbus, Ohio, United States
Jackson, Mississippi, United States
Lakeland, Florida, United States
San Antonio, Texas, United States
Bellevue, Washington, United States
Birmingham, Alabama, United States
Buffalo, New York, United States
Jacksonville, Florida, United States
Northridge, California, United States
North Kansas City, Missouri, United States
Sayre, Pennsylvania, United States
Saint Louis, Missouri, United States
Colorado Springs, Colorado, United States
Hershey, Pennsylvania, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Worcester, Massachusetts, United States
Ogden, Utah, United States
Camp Hill, Pennsylvania, United States
Johnson City, Tennessee, United States
Columbia, South Carolina, United States
Springfield, Missouri, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Bakersfield, California, United States
Fullerton, California, United States
Glendale, California, United States
Norwalk, Connecticut, United States
Athens, Georgia, United States
Baltimore, Maryland, United States
Minneapolis, Minnesota, United States
Cherry Hill, New Jersey, United States
Las Cruces, New Mexico, United States
Akron, Ohio, United States
Amarillo, Texas, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Patients applied
Trial Officials
Michael Gibson, MD
Principal Investigator
Boston Clinical Research Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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