Berlin Heart EXCOR Pediatric VAD, Руководство пользователя

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Chapter 3 Summary of Clinical Studies
Inclusion Criteria
• Patient requires mechanical circulatory support and is eligible for cardiac
transplantation
• Legal guardian and patient (if age appropriate) understands the nature of the
implant procedure and are willing to comply with associated follow-up
evaluations, and provide written informed consent and assent prior to the
procedure
Exclusion Criteria
• Patient is currently enrolled in EXCOR
®
Pediatric pre market study
• Patient is currently participating in another investigational device or drug trial
which would confound the results of the study
3.7.4 Data source
Berlin Heart sponsored web-based Registry.
3.7.5 Key Study Endpoints
Primary Safety Objective / Endpoint
The primary safety objective of the study was to demonstrate that the serious adverse
event (SAE) rate in subjects implanted with the EXCOR
®
Pediatric in this study was
not greater than the rate experienced in the IDE study.
The primary endpoint was the SAE rate which was calculated as the total number of
SAEs divided by the sum of days all subjects were supported on the EXCOR
®
Pediatric device.
A clinical events committee (CEC) met regularly during the course of the study to
adjudicate the protocol-specified SAEs: major bleeding, major infection and
neurological dysfunction events, and device malfunctions. The CEC also reviewed
and assigned cause of death to any subject who died as a result of withdrawal of
device support.
Primary Efficacy Objective / Endpoint
The primary effectiveness objective for the study was to assess the outcome following
implantation of the EXCOR® Pediatric for transplant eligible children in need of
mechanical circulatory support. The endpoint was defined as transplant, recovery of
left ventricular function or death.
3.7.6 Total number of Enrolled Study Sites and Subjects, Follow-up Rate
A total of 39 subjects were enrolled at 19 investigational sites. All subjects were
followed for the duration of device support. Subjects explanted from the device will
continue to be followed for 24 months post explant.
3.7.7 Study visits and length of follow-up
Clinical data recorded in hospital records was collected at the time of pre-implant,
implant, planned follow-ups (3 weeks, 6 weeks, 3 months, 6 months and every 3
months thereafter while on device support and up to transplant/recovery). Following
explant of the device, follow-up visits were scheduled at hospital discharge, 12 months
post explant and 24 months post explant.
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