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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXCOR Pediatric | Pediatric (age 0 - 21) patients who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXCOR Pediatric | Device | Mechanical circulatory support using ventricular assist device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric (0-21 years) who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Kroslowitz, BS | Berlin Heart, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sites per Action network | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D018487 | Ventricular Dysfunction, Left |
| D018497 | Ventricular Dysfunction, Right |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Until discontinuation of device support or 180 days |