CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary BypassStudy Description
The Levitronix CentriMag Ventricular Assist Device is designed for short-term (usually <14 days) of support for patients with left or right ventricular failure. This external, centrifugal blood pump uses 3rd generation magnetic technology to provide circulatory support to the body, while permitting the heart to rest and recover. The Failure-to-Wean from Cardiopulmonary Bypass trial evaluates the safety and effectiveness of the CentriMag VAD to help patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass. The primary endpoint is survival 30 days post support and/or discharge from the hospital.
Inclusion Criteria: (The following are general criteria; contact the study coordinator for more specific criteria):
• At least 18 years of age male or female
• 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:
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: (The following are general criteria; contact the study coordinator for more specific criteria):
• BUN > 100 mg/dl
• Creatinine > 5 mg/dl
• Presence of any investigational mechanical circulatory support device
• Known history of lever 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
How long does the study run?
This trial started enrolling in Oct 2008 and will continue until 30 patients have been enrolled.
Location(s) of the Clinic Trial
Up to 25 sites throughout the United States will participate in this trial. Please see www.clinictrials.gov for a complete list or talk to the study coordinator.
Status: Open to Enrollment
Name, Phone, Email:
Erin Davis, RN
Craig Selzman, M.D.
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. For more specific questions regarding eligibility, a clinic visit may be needed to determine if you are eligible for this study. If you have specific questions regarding your condition which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.
Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.