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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: CentriMag Ventricular Assist System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CentriMag Ventricular Assist System<br>All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System. | Device: CentriMag Ventricular Assist System<br>* All eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Number of patients alive 30 days after device implantation | 30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP) | Change in mean CVP while on pump support and in MAP during pump support. CVP and MAP were measured daily during pump support and the mean CVP and MAP during pump support were compared to baseline. Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP. | Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Dysfunction, Failure-to-wean from CPB, CentriMag, Levitronix, Thoratec Corporation