CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:October 2008
End Date:September 2013

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Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial

The purpose of the study is to evaluate the safety and effectiveness of the CentriMag
ventricular assist system to help patients who have experienced heart failure during surgery
and cannot be removed from cardiac bypass.


Inclusion Criteria:

- At least 18 years of age

- Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass

- Subjects who are on IABP, CPB, ECMO or CPS support prior to evaluation should have the
device turned off, if possible, for the purpose of measuring inclusion hemodynamics.
However, these devices should not be turned off in patients who would be harmed by
interruption of support.

- All subjects must meet the following criteria at the time of enrollment:

- Hemodynamics:

1. cardiac index ≤ 2.2 L/min/m2

2. For patients being evaluated for left-sided support (LVAD): PCWP ≥ 18 mmHg or
PADP ≥ 18 mmHg or LAP ≥ 18 mmHg

3. For patients being evaluated for right or biventricular support: CVP ≥ 15 mmHg or
RAP ≥ 15 mmHg and RVSWI ≤ 4.1 gm/m2/beat

4. Enrollment without hemodynamic measurements due to frequent or unpredictable
dysrhythmias, unacceptable cardiac function, or hemodynamic instability is
allowed.

- Placement of an intra-aortic balloon pump has been attempted unless contraindicated

- All possible measures have been attempted to correct low arterial pH, arterial blood
gas abnormalities, electrolytes, hypovolemia, hypervolemia, inadequate cardiac rate,
dysrhythmias and residual hypothermia

- Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if
appropriate and possible) has been attempted

- Written, signed, and dated informed consent

Exclusion Criteria:

- BUN > 100 mg/dl

- Creatinine > 5 mg/dl

- Presence of any investigational mechanical circulatory support device

- Known history of liver cirrhosis or portal hypertension

- Pulmonary infarction

- Stroke, TIA or history of either condition within the last six months and/or any
confirmed, existing neurologic deficits

- Active systemic infection defined as positive blood cultures, core temperature >100.5
degrees, white blood count > 12,500, and treatment with antimicrobials

- Participation in a clinical trial with any experimental treatment within 30 days prior
to screening or previous participation in the present study

- Other serious disease(s) limiting life expectancy
We found this trial at
14
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Lexington, Kentucky
859) 257-9000
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Houston, Texas 77030
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Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Minneapolis, Minnesota 55455
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Minneapolis, MN
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New York, New York 10032
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Phoenix, Arizona 85254
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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