ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
- Registration Number
- NCT01424722
- Lead Sponsor
- Abbott Medical Devices
- 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 Feature in St Jude Medical ICD systems.
- 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2258
-
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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ST Monitoring Feature Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices ST segment continous monitoring feature enabled and programmed ON
- Primary Outcome Measures
Name Time Method Number of Patients Who Experience a False Positive ST Detection in 12 Months FU 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (96)
MedStar Research Institute
🇺🇸Baltimore, Maryland, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Haddon Heights, New Jersey, United States
Allegheny-Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
VA Medical Center Dallas
🇺🇸Dallas, Texas, United States
The Heart Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
VA Medical Center Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Cardiology Consultants
🇺🇸Johnson City, Tennessee, United States
Heart Clinic of Hammond
🇺🇸Hammond, Louisiana, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Carondelet Specialist Group - Southwest Heartr
🇺🇸Tucson, Arizona, United States
Upstate Cardiology
🇺🇸Greenville, South Carolina, United States
Lourdes Cardiology Services
🇺🇸Cherry Hill, New Jersey, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Cardiology Associates of Fairfield County
🇺🇸Norwalk, Connecticut, United States
Banner Heart Hospital
🇺🇸Mesa, Arizona, United States
Columbia Cardiology Consultants
🇺🇸Columbia, South Carolina, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Arkansas Cardiology
🇺🇸Little Rock, Arkansas, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Kaiser Permanente Los Angeles
🇺🇸Los Angeles, California, United States
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
Central Cardiology
🇺🇸Bakersfield, California, United States
Colorado Cardiac Alliance
🇺🇸Colorado Springs, Colorado, United States
St. Jude Hospital
🇺🇸Fullerton, California, United States
USC University Hospital
🇺🇸Los Angeles, California, United States
Cardiac Rhythm Specialists, Inc.
🇺🇸Northridge, California, United States
Long Beach Memorial
🇺🇸Long Beach, California, United States
John Muir Medical Center
🇺🇸Concord, California, United States
North Kansas City Hospital
🇺🇸North Kansas City, Missouri, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Cardiology Consultants PA
🇺🇸Daytona Beach, Florida, United States
Watson Clinic Center
🇺🇸Lakeland, Florida, United States
Redmond Regional Medical Center
🇺🇸Rome, Georgia, United States
Athens Regional Medical Center
🇺🇸Athens, Georgia, United States
Mid-America Cardiology Associates, PC
🇺🇸Kansas City, Kansas, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Massachusettts Medical Center
🇺🇸Worcester, Massachusetts, United States
Shady Grove Adventist Hospital
🇺🇸Rockville, Maryland, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Mercy Medical Research Institute
🇺🇸Springfield, Missouri, United States
Ohio State Univeristy
🇺🇸Columbus, Ohio, United States
Stony Brook Medical Center
🇺🇸Stony Brook, New York, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
Thoracic Cardiovascular Healthcare Foundation
🇺🇸Lansing, Michigan, United States
Cardiovascular Associates of East Texas
🇺🇸Tyler, Texas, United States
Cardiology Center of Amarillo, LLP
🇺🇸Amarillo, Texas, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
McKay-Dee Heart Services
🇺🇸Ogden, Utah, United States
South Texas Cardiovascular Consultants
🇺🇸San Antonio, Texas, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
The Hope Heart Institute
🇺🇸Bellevue, Washington, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Cardiovascular Associates PC
🇺🇸Birmingham, Alabama, United States
University Hospital - Univ. of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
Arizona Arrhythmia Research Center
🇺🇸Phoenix, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
St. Thomas Hospital Heart
🇺🇸Nashville, Tennessee, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
First Coast Cardiovascular Institute
🇺🇸Jacksonville, Florida, United States
Northern Indiana Research Alliance
🇺🇸Fort Wayne, Indiana, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Kentucky Heart Institute / King's Daughter
🇺🇸Ashland, Kentucky, United States
Buffalo Heart Group
🇺🇸Buffalo, New York, United States
Southwest Heart PC
🇺🇸Las Cruces, New Mexico, United States
Penn State Milton Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States
Northeast Georgia Heart Center, PC
🇺🇸Gainesville, Georgia, United States
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
Scripps Memorial Hospital La Jolla
🇺🇸La Jolla, California, United States
Cardia Care Specialists
🇺🇸Glendale, California, United States
Glendale Memorial Hospital and Medical Center
🇺🇸Glendale, California, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
Englewood Hospital & Medical Center
🇺🇸Englewood, New Jersey, United States
Northeast Ohio Cardiovascular Associates
🇺🇸Akron, Ohio, United States
Donald Guthrie Foundation for Education and Research
🇺🇸Sayre, Pennsylvania, United States
Oklahoma Heart Institute at Utica
🇺🇸Tulsa, Oklahoma, United States
Capital Cardiovascular Associates
🇺🇸Camp Hill, Pennsylvania, United States
University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
EMH Regional Medical Center
🇺🇸Elyria, Ohio, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Sutter Memorial Hospital
🇺🇸Sacramento, California, United States
Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Hunter Holmes McGuire VAMC
🇺🇸Richmond, Virginia, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States