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

Stopped early · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01424722

Run by

Abbott Medical Devices

People needed

2258

Starts

2011-08-01

Expected to finish

2017-06-01

Last updated by the study team

2021-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cardiovascular Associates PC — Birmingham, Alabama, United States
• University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
• Heart Center Research, LLC — Huntsville, Alabama, United States
• Banner Heart Hospital — Mesa, Arizona, United States
• Arizona Arrhythmia Research Center — Phoenix, Arizona, United States
• Carondelet Specialist Group - Southwest Heartr — Tucson, Arizona, United States
• Arkansas Cardiology — Little Rock, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Central Cardiology — Bakersfield, California, United States
• John Muir Medical Center — Concord, California, United States
• St. Jude Hospital — Fullerton, California, United States
• Cardia Care Specialists — Glendale, California, United States
• Glendale Memorial Hospital and Medical Center — Glendale, California, United States
• Scripps Memorial Hospital La Jolla — La Jolla, California, United States
• Long Beach Memorial — Long Beach, California, United States
• Kaiser Permanente Los Angeles — Los Angeles, California, United States
• USC University Hospital — Los Angeles, California, United States
• Cardiac Rhythm Specialists, Inc. — Northridge, California, United States
• Sutter Memorial Hospital — Sacramento, California, United States
• Colorado Cardiac Alliance — Colorado Springs, Colorado, United States
• Cardiology Associates of Fairfield County — Norwalk, Connecticut, United States
• Christiana Hospital — Newark, Delaware, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Manatee Memorial Hospital — Bradenton, Florida, United States
• Cardiovascular Associates PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.