22
while patients are on the device and device malfunctions and failures are not indication-specific, data from patients enrolled in all
four studies were used to assess the safety of the device. A summary of the clinical studies is presented below.
Study Design
Patients were treated in the four clinical studies between May 2004 and December 2013. There were 14 unique investigational
sites across the four studies as shown in the table below. Each patient was followed for 6 months post-device removal in the three
pre-market studies and for 30 days post-device removal in the HDE post-approval study.
Table 6. CentriMag Clinical Studies
Study
Cardiogenic Shock Trial
RVAS Trial
Failure to Wean
From CPB
Pivotal Trial
RVAS HDE
Post-Approval
Study
FDA IDE No.
G030052
G040029
G030052/S21
H070004/S1
Start Enrollment
May 2004
Oct 2004
Oct 2008
Feb 2010
End Enrollment
Dec 2007
Feb 2008
March 2013
Dec 2013
Investigational Sites
6
2
8
7
Patients
26
12
32
25
The pivotal trial conducted under IDE G030052/S21 enrolled only post-cardiotomy patients who failed to wean from CPB, the
primary indication for use in the US, while the other three studies included patients enrolled for other indications as well.
The Failure to Wean from CPB pivotal trial (G030052/S21) utilized a Data Safety Monitoring Board (DSMB) and Clinical Events
Committee (CEC). The CEC was responsible for adjudicating all adverse events occurring during the study. The DSMB was
responsible for reviewing adverse events, data quality, endpoints, device efficacy data and overall study conduct to evaluate device
safety.
Data were compared to outcomes of patients who failed to wean from cardiopulmonary bypass and who required mechanical
circulatory support, as reported in peer-reviewed, published scientific literature.
The failure to wean from CPB population was defined as a subset of patients suffering from post-cardiotomy cardiogenic shock who
were unable to be separated from CPB prior to leaving the operating room.
Clinical Inclusion Criteria
Enrollment in the studies was limited to patients at least 18 years of age for whom informed consent was given either by the
patient or their legally authorized representative, and who met the following inclusion criteria.
Inclusion Criteria – Failure to Wean from Cardiopulmonary Bypass Pivotal Trial (G030052/S21)
Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass.
All potential subjects must meet the following hemodynamic criteria at the time of enrollment:
o
Cardiac index ≤ 2.2 L/min/m
2
.
o
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.
o
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
2
/beat.
o
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.
Table 7. Inclusion Criteria – Other Premarket CentriMag System Pilot Studies
G030052
G040029
Cardiogenic Shock Trial
CentriMag RVAS
Potentially reversible cardiogenic shock with one of the
following diagnoses:
Post-cardiotomy cardiogenic shock
Undergoing treatment with an LVAS as a bridge to
transplant or for destination therapy
7
Fourteen unique investigational sites; many sites participated in more than one study.
