Heart Transplant
Conditions
Brief summary
The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies.
Interventions
DEVICEOCS Heart
Transplanted with OCS preserved heart.
Sponsors
TransMedics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient survival | 5 years post-transplant | Patient survival through 5 years post-transplant |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiac related patient survival | 5 years post-transplant | Cardiac related patient survival through 5 years post-transplant |
| Graft survival | 5 years post-transplant | Graft survival through 5 years post-transplant |
| Patient and graft survival | 5 years post-transplant | Patient and graft survival through 5 years post-transplant |
Countries
United States
Outcome results
None listed