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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Berlin Heart Comprehensive Reg Based Surv

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Study Status Progress Adequate
Application Number P160035 / PAS001
Date Current Protocol Accepted  
Study Name Berlin Heart Comprehensive Reg Based Surv
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 Design Description 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 Description 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%.

Data Collection 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.

Follow-up Visits and Length of Follow-up Patients are to be followed for 180 days post implant or to outcome (whichever is earlier).

Interim or Final Data Summary
Interim Safety Information 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.
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.
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.
Patient Follow-up Rate The follow-up rate is near 100 percent with some subjects not having data entered for interim follow-up visits.
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.

Berlin Heart Comprehensive Reg Based Surv Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 12/05/2017 01/08/2018 Overdue/Received
one year report 06/06/2018 06/07/2018 Overdue/Received
18 month report 12/05/2018 12/06/2018 Overdue/Received
two year report 06/06/2019 06/06/2019 On Time
30 month report 12/06/2019 12/06/2019 On Time
final report 06/05/2020 06/05/2020 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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