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Keep this study
Lead
Abbott Medical Devices
With
Thoratec Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass
