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

Berlin Heart

Status: Unknown

Conditions: Ventricular Dysfunction, Left; Ventricular Dysfunction; Ventricular Dysfunction, Right

Treatments: Device: EXCOR Pediatric

Study type: Observational

Funder types: Industry

Identifiers

NCT03701997

EXCOR PMA Post Approval

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 1 day to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Transplant eligible
• Implanted with EXCOR Pediatric per IFU

Exclusion criteria

• Having any contradictions for user per IFU

Trial design

62 participants in 1 patient group

EXCOR Pediatric

Description:

Pediatric (age 0 - 21) patients who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric

Treatment:

Device: EXCOR Pediatric