Brief Summary
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.
Brief Title
OCS Heart Perfusion Post-Approval Registry
Detailed Description
Multi-center, observational post-approval registry to:
1. compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
2. compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.
1. compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
2. compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.
Completion Date
Completion Date Type
Estimated
Conditions
Transplant
Eligibility Criteria
Inclusion Criteria:
* Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.
Recipient Exclusion Criteria:
* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* On renal dialysis at time of transplant.
Donor Exclusion Criteria (for DCD Donor Hearts only):
* Warm ischemic time \> 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).
* Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.
Recipient Exclusion Criteria:
* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* On renal dialysis at time of transplant.
Donor Exclusion Criteria (for DCD Donor Hearts only):
* Warm ischemic time \> 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).
Inclusion Criteria
Inclusion Criteria:
* Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.
Recipient
* Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.
Recipient
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05047068
Org Class
Industry
Org Full Name
TransMedics
Org Study Id
OCSHEART-01-ClinPAS
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
OCS Heart Perfusion (OHP) Post-Approval Registry
Primary Outcomes
Outcome Description
Patient survival at one-year post-heart transplant.
Outcome Measure
Patient Survival
Outcome Time Frame
One year post-heart transplant
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Participants will be adult primary heart transplant potential recipients on the waiting list for heart transplantation at the participating Registry centers.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Goldstein
Investigator Email
dgoldste@montefiore.org