|
General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P180051 S001/ PAS002 |
Date Original Protocol Accepted |
04/27/2022
|
Date Current Protocol Accepted |
 
|
Study Name |
Post-commercialization DCD New Enrollment Study
|
Device Name |
OCS Heart System
|
Clinical Trial Number(s) |
NCT03831048
NCT04615182
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
External Registry
|
Comparison Group |
Concurrent Control
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
This is a prospective, multi-center, single-arm new enrollment study. The objective of the study is to characterize the performance of the OCS Heart System in the real-world setting, as compared to concurrent control data obtained from the United Network for Organ Sharing (UNOS) database for recipients of standard criteria donor hearts preserved using cold static cardioplegic storage.
|
Study Population |
Patients needing heart transplant.
|
Sample Size |
150 patients that constitute the Primary Analysis Population.
|
Key Study Endpoints |
The primary endpoint is patient survival at 1 year post-transplant. Other endpoints include patient/graft survival through 5 years posttransplant, incidence of moderate or severe primary graft dysfunction (PGD; left or right ventricle), and incidence of donor heart turndowns following OCS Heart System perfusion.
|
Follow-up Visits and Length of Follow-up |
5 years
|
Interim or Final Data Summary |
Interim Results |
Safety Results Graft survival @ 6 months: 97.6% (OCS DCD cohort) vs. 98.8% (SOC cohort) – Non-inferiority met.
Effectiveness Results Patient survival @ 1 year: 91.6% (OCS DCD cohort) vs. 93.9% (SOC cohort) – Non-inferiority met.
|
Actual Number of Patients Enrolled |
Primary Analysis Population: 167 (OCS DCD cohort) and 607 (Standard of Care [SOC] cohort: standard criteria donor hearts preserved using cold static cardioplegic storage)
|
Actual Number of Sites Enrolled |
24
|
Patient Follow-up Rate |
100%; no patients have been lost to follow-up in the OCS DCD cohort.
|