Ignite Creation Date:
2024-05-06 @ 12:43 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03831048
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2019-01-22
Brief Title:
Donors After Circulatory Death Heart Trial
Sponsor:
TransMedics
Organization:
TransMedics
Study Overview
Official Title:
Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System OCS Heart For Resuscitation Preservation and Assessment of Hearts From Donors After Circulatory Death DCD Heart Trial
Status:
COMPLETED
Status Verified Date:
2022-12
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:
To evaluate the effectiveness 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
Detailed Description:
A prospective randomized and concurrent controlled non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant Standard of Care 1 SOC1 and Standard of Care 2 SOC2 - from both randomized and concurrent control groups adjusting for differences in risk factors
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