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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

32

Study ID:

NCT00819793

Recruitment Status:

Completed

Sponsor:

Abbott Medical Devices

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 14 Locations for this study

See Locations Near You

Mayo Clinic Hospital, Arizona
Phoenix Arizona, 85054, United States
Yale University
New Haven Connecticut, 06510, United States
University of Kentucky
Lexington Kentucky, 40536, United States
University of Maryland
Baltimore Maryland, 21201, United States
Fairview University Medical Center
Minneapolis Minnesota, 55455, United States
New York Columbia Presbyterian Hospital
New York New York, 10032, United States
University of Rochester
Rochester New York, 14642, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
St. Luke's Episcopal
Houston Texas, 77030, United States
Intermountain Medical Center
Murray Utah, 84107, United States
University of Utah
Salt Lake City Utah, 84132, United States
St. Luke's Medical Center
Milwaukee Wisconsin, 53215, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

32

Study ID:

NCT00819793

Recruitment Status:

Completed

Sponsor:


Abbott Medical Devices

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider