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

Ventricular Dysfunction Clinical Trial

Official title:
All-comers Registry Monitoring the Safety and Effectiveness of the Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.

Clinical Trial Summary

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.

Clinical Trial Description

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03701997
Study type Observational [Patient Registry]
Source Berlin Heart, Inc
Contact
Status Enrolling by invitation
Phase
Start date October 15, 2018
Completion date May 2022
View Details
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