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

Status unconfirmed

Conditions studied: Ventricular Dysfunction, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right

In brief

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.

Key facts

Study ID

NCT03701997

Run by

Berlin Heart, Inc

People needed

62

Starts

2018-10-15

Expected to finish

2022-05-01

Last updated by the study team

2018-10-10

Who can join

Age: 0 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Transplant eligible
• Implanted with EXCOR Pediatric per IFU

You may not qualify if…

• Having any contradictions for user per IFU

Where it is running

• Sites per Action network — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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