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



Status:Terminated
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:August 2011
End Date:June 2017

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ST Monitoring to Detect ACS Events in ICD Patients

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.

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.

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.
We found this trial at
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Columbus, Ohio 43210
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
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Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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Ocala, Florida 34471
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Albuquerque, New Mexico 87102
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Athens, Georgia 30606
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Bakersfield, California 93308
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Baltimore, Maryland 21237
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Bellevue, Washington 98004
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Bradenton, Florida 34208
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Browns Mills, New Jersey 08015
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Buffalo, New York 14215
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Camp Hill, Pennsylvania 17011
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Cherry Hill, New Jersey 08034
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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2049 E 100th St
Cleveland, Ohio 44106
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Colorado Springs, Colorado 80907
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Columbia, South Carolina 29204
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Columbus, Ohio 43214
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Concord, California 94520
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Elyria, Ohio 44035
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350 Engle St
Englewood, New Jersey 07631
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Fullerton, California 92835
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1301 Punchbowl St
Honolulu, Hawaii 96813
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La Jolla, California 92037
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1740 Nicholasville Rd
Lexington, Kentucky 40503
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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500 S Preston St
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1400 NW 12th Ave
Miami, Florida 33136
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
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600 Gresham Dr
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North Kansas City, Missouri 64116
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Northridge, California 91325
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200 Lothrop St
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16001 W 9 Mile Rd
Southfield, Michigan 48075
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Spartanburg, South Carolina 29303
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2401 S. 31st Street
Temple, Texas 76508
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Traverse City, Michigan 49684
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110 Irving St NW
Washington, District of Columbia 20010
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Winston-Salem, North Carolina 27103
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Worcester, Massachusetts 01655
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