Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.

2018-10-17 12:26:19 | BioPortfolio


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 Design


Ventricular Dysfunction


EXCOR Pediatric


Sites per Action network
United States


Enrolling by invitation


Berlin Heart, Inc

Results (where available)

View Results


Published on BioPortfolio: 2018-10-17T12:26:19-0400

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