Acute Study to Collect Electrical Signals From the Heart Using a Special Lead



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/21/2018
Start Date:May 2016
End Date:August 2017

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Acute Extravascular Defibrillation Study

The main purpose of this clinical study is to collect electrograms from an investigational
lead placed in an extravascular space, for development of a future Implantable Cardioverter
Defibrillator (ICD) system.


Inclusion Criteria:

- Subject must be undergoing surgical procedure for approved indications for:

- cardiothoracic surgery where a midline sternotomy is planned, or

- cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is
planned, or

- VT ablation procedure with epicardial access, or

- implant of a subcutaneous ICD (S-ICD®), or implant of a transvenous ICD (single
or dual chamber)

- Subject must be willing to provide Informed Consent

- Subject must be ≥ 18 years old

Exclusion Criteria:

- Subject has known hiatus hernia or moderate or worse pectus excavatum

- Subject had previous pericarditis or prior sternotomy

- Subject has known significant Right Ventricle/ Right Ventricular dilation

- Subject has hypertrophic cardiomyopathy

- Subject is pacemaker dependent

- Subject has known skin irritations due to the Covidien Multi-function defibrillation
electrode

- Subject is considered to be at high risk for infection(1)

- Subject has Left Ventricular Ejection Fraction < 20% (most recent available LVEF
measurement in the last 6 months)

- Subject has New York Heart Association Class IV

- Subject has myocardial infarction within the last 6 weeks

- Subject currently has unstable angina

- Subject has severe aortic stenosis

- Subject at high risk of stroke (2)

- Subject has Chronic Obstructive Pulmonary Disease and is oxygen dependent

- Subject has permanent AF and will not be adequately anticoagulated during the ASD2
Acute Testing procedure (3)

- Subject with an implanted active cardiac or non-cardiac device during the ASD2 Acute
Testing procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)

- Subject is enrolled in a concurrent study that may confound the results of this study,
without documented pre-approval from a Medtronic study manager

- Subject has any medical condition that would limit study participation

- Subject is pregnant, or of childbearing potential and not on a reliable form of birth
control. Women of childbearing potential are required to have a negative pregnancy
test within 7 days prior to the ASD2 Acute Testing procedure

- Subject meets exclusion criteria required by local law (e.g. age, breast feeding,etc.)

- Subject is legally incompetent

1. Screening subjects at high risk for infection will be based on the local
investigator judgment decision.

2. Subjects who are at high risk for stroke should be screened according to local
country guidelines or, in case of their absence, according to ACC/AHA/ESC 2006
Guidelines for High Risk Factors for Stroke (i.e. exclusion of subjects with
previous stroke, TIA, or embolism; Mitral stenosis; prosthetic heart valve).

3. Screening will be based on the local investigator judgment decision.
We found this trial at
15
sites
303 East Superior Street
Chicago, Illinois 60611
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Cherry Hill, New Jersey 08034
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Des Moines, Iowa 50314
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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145 Studley Road
Heidelberg, Victoria 3084
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Jacksonville, Florida 32207
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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170 William Street
New York, New York 10038
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New York, New York 10016
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Raleigh, North Carolina
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Rochester, Minnesota 55905
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Scottsdale, Arizona 85251
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