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Table 7. Inclusion Criteria – Other Premarket CentriMag System Pilot Studies
G030052
G040029
Cardiogenic Shock Trial
CentriMag RVAS
Post-Acute Myocardial Infarction cardiogenic shock
Potentially reversible cardiogenic shock following myocardial
infarction (AMI) subjects must meet two of the following three
criteria:
History and physical consistent with acute myocardial
infarction
ECG changes consistent with AMI
Serum cardiac protein or enzyme changes consistent with AMI
Not applied to this study
Potentially reversible post-cardiotomy cardiogenic shock
following a cardiac surgical procedure subjects must be within
6 hours of the surgical procedure.
Potentially reversible post-cardiotomy cardiogenic shock
following implantation of an FDA cleared, commercially
available LVAS. Enrollment must be within 24 hours of
the surgical procedure to implant the LVAS
For patients considered for LVAS support:
PCWP ≤ 18 mmHg or
PAD ≤ 18 mmHg or
LAP ≤ 18 mmHg
With cardiac index ≤ 2.0 l/min/m
2
Not applied to this study
Patients supported with a CentriMag LVAS, with a dilated right
ventricle, and being considered for BVAS support must meet
two of the following three criteria:
Patients being considered for RVAS support must meet two
of the following three criteria:
CVP or RVP ≥ 15 mmHg
Right Ventricular Stroke Work Index (RVSWI) ≤ 4.1 gm-m
2
/beat
Decrease in mean PAP ≤ 10 mmHg following the initiation of LVAS support
For patients unweanable from CPB:
No hemodynamic inclusion criteria required for either LVAS
or BVAS support
For patients unweanable from CPB and being considered for
BVAS support:
No hemodynamic inclusion criteria required for RVAS
support
Patient is unable to maintain adequate hemodynamics due
to dysrhythmias:
No hemodynamic inclusion criteria required for either LVAS
or BVAS support
Not applied to this study
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.
The only inclusion criterion for the post-approval study of the CentriMag RVAS HDE (H070004/S1) was 25 consecutive patients
with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.
Clinical Exclusion Criteria
Patients were not permitted to enroll in the three premarket studies if they met any of the following exclusion criteria. No exclusion
criteria were specified in the post-approval study protocol for the CentriMag RVAS HDE (H070004/S1).
Table 8. Exclusion Criteria – All CentriMag System Premarket Studies
G030052/S21
G030052
G040029
FTW from CBP Pivotal Trial
Cardiogenic Shock Trial
CentriMag RVAS
BUN > 100 mg/dl. (Based on lab data from the 24 hours prior to enrollment).
Creatinine > 5 mg/dl (Based on lab data from the 24 hours prior to enrollment).
Presence of any investigational mechanical circulatory support device.
Presence of any ongoing mechanical
circulatory support device, other than
a commercially approved LVAS and an
intra-aortic balloon pump.
Not applied to this study
On an Abbott Medical PVAD (LVAD)
undergoing treatment for failure to
wean from CPB.
Not applied to this study
Presence of any mechanical cardiac valve prosthesis
Known history of liver cirrhosis or portal hypertension.
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.
Not applied to this study
Fixed pulmonary hypertension with a PVR > 8 Wood units, unresponsive to
pharmacologic intervention, O2, NO, etc.
