Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04615182
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2020-10-28
Brief Title:
Donor After Circulatory Death Heart CAP Trial
Sponsor:
TransMedics
Organization:
TransMedics
Study Overview
Official Title:
The Portable Organ Care System OCS Heart For Resuscitation Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol OCS DCD Heart CAP
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Portable Organ Care System OCS Heart for Resuscitating Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol OCS DCD Heart CAP
Detailed Description:
To enable continued clinical access to DCD heart transplantation in the US and to continue to collect additional data on the performance of the OCS Heart System to resuscitate preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None