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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventricular Dysfunction, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right

Intervention / Treatment
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* Device: EXCOR Pediatric


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Transplant eligible Implanted with EXCOR Pediatric per IFU Exclusion Criteria: Having any contradictions for user per IFU

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EXCOR Pediatric<br>Pediatric (age 0 - 21) patients who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric | Device: EXCOR Pediatric<br>* Mechanical circulatory support using ventricular assist device<br>* Other names: EXCOR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke rate | The primary endpoint is to demonstrate that the rate of stroke (ischemic or hemorrhagic) will be no worse than the pre-specified performance goal. The rate will be calculated as the proportion of subjects experiencing a stroke while on EXCOR® Pediatric support within the first 180 days post-implant. The upper bound of the 95% confidence interval for the observed stroke rate will be compared to the pre-specified performance goal of 30%. | Until discontinuation of device support or 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse Event rates per patient-month | Until discontinuation of device support or 180 days | 
| Device effectiveness | Proportion of subjects experiencing a successful (transplant, wean for recovery) outcome | Until discontinuation of device support or 180 days |