Status:Recruiting
Keywords:Heart failure
, bridge to recovery
, lvad
, bridge to transplant
, cardiogenic shock
, post-cardiotomy shock
IRB Number:00033738
Specialty:Cardiothoracic Surgery
Sub Specialty:Heart Failure
Prospective, non-randomized, open-label, multi-center study. 70 patients. Up to 25 sites.
Treatment Group: Patients who have cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass after an operative procedure and are unable to leave the operating room without mechanical circulatory support.
Control Group: Failure-to-wean patients reported in peer-reviewed published clinical reports that require mechanical circulatory support.
Endpoint: % of survivors to 30 days post-support or to hospital discharge (whichever is longer) in the treatment (CentriMag) group meets or exceeds the performance goal of 27%.
Prospective, non-randomized, open-label, multi-center study. 30 patients. Up to 25 sites
Principle Investigator: Craig Selzman
Principle Department: Cardiothoracic Divison
Co Investigator:
Name:Erin Davis
Phone:801-585-3188
Email:erin.davis@hsc.utah.edu
a. At least 18 years of age.
b. Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass.
c. 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.
d. All potential subjects must meet the following criteria at the time of enrollment:
Hemodynamics:
i. Cardiac index ≤ 2.2 L/min/m2.
ii. For patients being evaluated for left-sided support (LVAD):
Pulmonary Capillary Wedge Pressure (PCWP) ≥ 18 mmHg or
Pulmonary Artery Diastolic Pressure (PADP) ≥ 18 mmHg or
Left Atrial Pressure (LAP) ≥ 18 mmHg.
(Hemodynamics may be measured with or without RVAD support.)
iii. For patients being evaluated for Right or Biventricular support (BVAD):
Central Venous Pressure (CVP) ≥ 15 mmHg or
Right Atrial Pressure (RAP) ≥ 15 mmHg.
Right Ventricular Stroke Work Index (RVSWI) ≤ 4.1 gm•m/beat.
(Hemodynamics may be measured with or without LVAD support.)
iv. Enrollment without hemodynamic measurements due to frequent or unpredictable dysrhythmias, unacceptable cardiac function, or hemodynamic instability is allowed.
e. Placement of an intra-aortic balloon pump has been attempted unless contraindicated.
f. 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.
g. Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if appropriate and possible) has been attempted.
h. Written, signed, and dated informed consent.
a. BUN > 100 mg/dl. (Based on lab data from the 24 hours prior to enrollment).
b. Creatinine > 5 mg/dl (Based on lab data from the 24 hours prior to enrollment).
c. Presence of any investigational mechanical circulatory support device.
d. Known history of liver cirrhosis or portal hypertension.
e. Pulmonary infarction. Pulmonary angiograms with evidence of significant embolism within two weeks prior to consideration. A significant embolism is one that causes lung infarction in more than one lung segment proven by a V/Q scan or pulmonary angiogram.
f. Stroke, TIA or history of either condition within the last six months and/or any confirmed, existing neurologic deficits.
g. Active systemic infection defined as positive blood cultures, core temperature >100.5°F, white blood count > 12,500, and treatment with antimicrobials.
h. Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study.
i. Other serious disease(s) limiting life expectancy.
