The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (\<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric.
The Advanced Cardiac Therapies Improving Outcomes Network (Action) database will be used for the surveillance. The network was developed to determine best practice and improve quality in the pediatric mechanical circulatory support field. The registry Protocol and Manual of Operations will be followed by participating pediatric transplant hospitals. Quality assurance of the data will be monitored by the registry's data coordinating center.
Study Type
OBSERVATIONAL
Enrollment
62
Mechanical circulatory support using ventricular assist device
Sites per Action network
Cincinnati, Ohio, United States
Stroke rate
The primary endpoint is to demonstrate that the rate of stroke (ischemic or hemorrhagic) will be no worse than the pre-specified performance goal. The rate will be calculated as the proportion of subjects experiencing a stroke while on EXCOR® Pediatric support within the first 180 days post-implant. The upper bound of the 95% confidence interval for the observed stroke rate will be compared to the pre-specified performance goal of 30%.
Time frame: Until discontinuation of device support or 180 days
Adverse Events
Adverse Event rates per patient-month
Time frame: Until discontinuation of device support or 180 days
Device effectiveness
Proportion of subjects experiencing a successful (transplant, wean for recovery) outcome
Time frame: Until discontinuation of device support or 180 days
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