Heart Failure Clinical Trial
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass
Summary
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.
Eligibility Criteria
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:
cardiac index ≤ 2.2 L/min/m2
For patients being evaluated for left-sided support (LVAD): PCWP ≥ 18 mmHg or PADP ≥ 18 mmHg or LAP ≥ 18 mmHg
For patients being evaluated for right or biventricular support: CVP ≥ 15 mmHg or RAP ≥ 15 mmHg and RVSWI ≤ 4.1 gm/m2/beat
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 14 Locations for this study
Phoenix Arizona, 85054, United States
New Haven Connecticut, 06510, United States
Lexington Kentucky, 40536, United States
Baltimore Maryland, 21201, United States
Minneapolis Minnesota, 55455, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Durham North Carolina, 27710, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Houston Texas, 77030, United States
Murray Utah, 84107, United States
Salt Lake City Utah, 84132, United States
Milwaukee Wisconsin, 53215, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.