Severe Biventricular Dysfunction Clinical Trial
Official title:
Berlin Heart EXCOR Pediatric Post Approval Study
The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether safety and outcomes of the device use in the commercial setting are comparable to the safety and outcomes of the device use in the IDE study.
EXCOR® Pediatric is intended to provide mechanical circulatory support as a bridge to
cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated
left ventricular or biventricular dysfunction who are candidates for cardiac transplant and
require circulatory support may be treated using the EXCOR® Pediatric.
Study Purpose The purpose of this post-approval study of the EXCOR® Pediatric VAD is to
evaluate whether safety and outcomes of the device use in the commercial setting are
comparable to the safety and outcomes of the device use in the IDE study. Because the device
had extensive use (available to all North American sites who requested the device under
compassionate use regulations), it is expected that the pre-approval and post-approval use
will be similar.
The primary safety objective of the EXCOR® Pediatric VAD Post-Approval Study is to
demonstrate that the serious adverse event (SAE) rate in subjects implanted with the EXCOR®
Pediatric in the study is not greater than the rate experienced in the IDE study.
The primary effectiveness objective for the EXCOR® Pediatric VAD Post Approval Study is to
assess the outcome following implantation of the EXCOR® Pediatric for transplant eligible
children in need of mechanical circulatory support. Outcome is defined as transplant,
recovery of left ventricular function or death.
The following secondary objectives will be summarized:
- Device Malfunction
- Site evaluation of explanted pumps for suspected thrombus
- Assessment of the learning curve
The study will be an "all-comers" prospective study maintained by the sponsor consisting of
pediatric patients aged 0-21 years implanted according to the IFU with the EXCOR® Pediatric
who are transplant eligible children in need of mechanical circulatory support and who
consent to be enrolled into the study.
The study will enroll at least 39 subjects implanted with the device per device labeling and
who consent to be enrolled into the post approval study after the study commencement at any
implanting site with IRB approval for participation.
Study enrollment is expected to take 10-12 months and subjects will be followed until they
reach an outcome. The primary endpoints will be analyzed and reported to FDA during the
regular reporting cycle. Explanted subjects will be followed for 24 months post explant. A
final report will be submitted to FDA once all subjects complete their 24 month post explant
visit. Average time on device is expected to be similar to the average time on the device
during the IDE study (58 days) therefore the last implant is expected to be followed until
outcome (IDE range was 0 - 435 days). The overall study duration is expected to be
approximately 36-38 months.
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Observational Model: Cohort, Time Perspective: Prospective