NCT03701997

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 62 (estimated)
• Sponsor: Berlin Heart, Inc · Industry
• Sex: All
• Age: 1 Day – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ventricular Dysfunction
• Ventricular Dysfunction, Left
• Ventricular Dysfunction, Right

Interventions

Type	Name	Description
DEVICE	EXCOR Pediatric	Mechanical circulatory support using ventricular assist device

Timeline

• Start date: 2018-10-15
• Primary completion: 2021-12-01
• Completion: 2022-05-01
• First posted: 2018-10-10
• Last updated: 2018-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study