Impella® RP with the Automated Impella® Controller
6.3
Screened for
Enrollment
N=175
Enrolled
N=30
Screening Failures
N=145
•
RV failure not present - 49 pts
•
CI > 2 L/min/m
2
- 17 pts
•
CVP < 15 mmHg - 12 pts
•
Insurance related issues - 11 pts
•
Critical cardiogenic shock - 6 pts
•
End-organ failure - 6 pts
•
History of DVT or IVC filter present / history of
thrombocytopenia or HIT / active infection - 4 pts
each
•
AMI w/ mechanical complication / on other RV
support - 3 pts each
•
Other - 26 pts
Cohort B
N=12
5 RVF post AMI-CS
2 RVF post cardiotomy
5 RVF post transplant
Cohort A
N=18
18 RVF post LVAD implantation
STUDY ORGANIZATION
ABIOMED was responsible for site management, site monitoring, data management and oversight of
safety processes. The study also included an independent Echocardiography Core Laboratory (Duke
Clinical Research Institute, Durham, NC) that provided imaging protocol design, site training/certification
and image management/analyses. A cardiothoracic surgeon, selected as the Physician Medical Monitor,
was charged with reviewing study data in order to protect the safety and well-being of human subjects
and the scientific integrity of the investigation. An independent CEC was organized through Harvard
Clinical Research Institute (HCRI) and comprised physicians trained in interventional cardiology, heart
failure and cardiac surgery who were experienced with the safety issues specific to mechanical
circulatory support. The CEC members reviewed adjudicated all adverse events and determined
whether a causal relationship to either the investigational device or the procedure existed.
STATISTICAL CONSIDERATIONS
Considering the low incidence of RVF and challenges to enroll patients in a reasonable time frame, the
study was not designed to be hypothesis driven. Data were described as mean ± standard deviation
(mean ± SD).
ACCOUNTABILITY OF COHORT
A total of 30 subjects were enrolled into the study. Of these 30 subjects, there were 18 subjects (60%)
enrolled in Cohort A and 12 subjects (40%) enrolled in Cohort B. Details are shown in Figure 6.1.
Figure 6.1 Study flow schematic
