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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160035 / PAS001 |
| Date Original Protocol Accepted |
05/21/2018
|
| Date Current Protocol Accepted |
|
| Study Name |
Berlin Heart Comprehensive Reg Based Surv
|
| Device Name |
EXCOR Pediatric Ventricular Assist Device
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The primary objective of the surveillance plan is to evaluate the
occurrence of stroke (ischemic or hemorrhagic) while on EXCOR Pediatric support within the first 180 days post-implant and if differences exist based on anticoagulation strategy.
|
| Study Population |
Children who are transplant eligible in need of mechanical
circulatory support and are supported with the EXCOR Pediatric will be included in this surveillance. No additional inclusion/exclusion criteria will apply. No comparative group will be included.
|
| Sample Size |
A minimum of 62 subjects implanted with EXCOR Pediatric will allow comparison to a pre-specified performance goal for stroke while on device of 30%.
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| Key Study Endpoints |
The primary endpoint for this study will be the rate of stroke (ischemic or hemorrhagic) within the first 180 days post- implant. The primary endpoint will also be stratified by anticoagulation regimen.
Secondary safety endpoint: Adverse Events will be summarized as the rate per patient-month.
Secondary effectiveness endpoint: Device effectiveness will be summarized as the proportion of subjects experiencing a successful outcome.
Successful outcome is defined as survival to recovery/successful weaning, or survival to transplant, or survival on EXCOR® Pediatric at 180 days post-implant.
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| Follow-up Visits and Length of Follow-up |
Patients are to be followed for 180 days post implant or to outcome (whichever is earlier).
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| Interim or Final Data Summary |
| Interim Results |
Interim Effectiveness Results reflect a cumulative incidence of “Success” (defined as survival to transplant, successful weaning, or survival on device at 180-days post-implant) in 32 of 44 subjects who have reached an endpoint (transplant, successful weaning, survival on device at 180-days post-implant, escalation of therapy, or death). Twelve subjects did not meet the success criteria for the study and either died (6) or were escalated from Berlin Heart therapy to a different therapy (6). Nine additional subjects were alive on-device at the data lock date for this report but had not yet reached the 180-day endpoint.
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| Actual Number of Patients Enrolled |
Fifty-three (53) subjects have been enrolled into the Action Learning Network’s Pediatric Ventricular Assist Device Registry for this study of the Berlin Heart EXCOR device.
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| Actual Number of Sites Enrolled |
Thirty-five sites have agreed to participate in the ACTION Learning Network Registry, 24 have the necessary paper work in place to start enrolling subjects and 16 of those sites are enrolling subjects.
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| Patient Follow-up Rate |
The follow-up rate is near 100 percent with some subjects not having data entered for interim follow-up visits.
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| Study Strengths & Weaknesses |
Strengths: This study collects detailed data from a registry that has the potential to provide an accurate representation of the safety and effectiveness of this device as it is used in “real world” practice. The follow-up rate is currently high and the registry is collecting data on the concomitant medication regimen being used.
Weaknesses: Adverse event data is not yet adjudicated. There is some data missingness for variables of interest. Additionally, it is not clear yet if these results of this registry can be assumed to be representative of the larger Berlin Heart population in North America. The sponsor will be asked to provide a comparison of the sites entering data to all implanting centers.
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