Berlin Heart EXCOR Pediatric Ventricular Assist Device Post Approval Study

Study ID
STU 082012-072

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Jessica Crockett
214.456.4213
jessica.crockett@childrens.com

Principal Investigator
Kristine Guleserian

Summary

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 instructions for use with the eXCoR[RegisteredTM] 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. Subjects enrolling in the post approval study will also be participating in the HuD study, STu 022012-036.

Participant Eligibility

Patient requires mechanincal 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.