Clinical trials: active, sponsored by TransMedics
Heart Transplant
OCS DCD Heart + CAP Continued Follow-Up
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.
- Trial name
- NCT05741723
- Testing
- OCS Heart
- Where
- 20 sites in United States
- Volunteers
- 276 people
- Sponsor
- TransMedics
Lung Transplant
Decreasing Edema With a Novel OCS Solution Trial
This is a prospective, multicenter randomized trial of lung transplant recipients transplanted with either a DBD or DCD donor lungs.
- Trial name
- DENOVO (NCT07340710)
- Testing
- OCS Lung System, Static Cold Storage
- Volunteers
- 450 people
- Sponsor
- TransMedics
Heart Transplant
Enhancing Heart Allograft Function With the OCS Heart System Trial
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation.
- Trial name
- ENHANCE (NCT07145515)
- Testing
- OCS Heart, Static Cold Storage (SCS)
- Where
- 8 sites in United States
- Volunteers
- 655 people
- Sponsor
- TransMedics
Transplant
OCS Heart Perfusion Post-Approval Registry
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.
- Trial name
- NCT05047068
- Testing
- OCS Heart System
- Where
- 27 sites in United States
- Volunteers
- 350 people
- Sponsor
- TransMedics
Heart Transplant
US National OCS Heart Perfusion (OHP) Registry
This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.
- Trial name
- NCT05915299
- Testing
- OCS Heart
- Where
- 37 sites in United States
- Volunteers
- 100,000 people
- Sponsor
- TransMedics
Lung Transplant
US National TOP Registry
The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the…
- Trial name
- NCT06513091
- Testing
- OCS Lung
- Where
- 7 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- TransMedics
Lung Transplantation
OCS™ Lung TOP Registry For Donor Lungs for Transplantation
Single-arm, prospective, multi-center, post-approval U.S. registry
- Trial name
- TOP (NCT03639025)
- Testing
- OCS Lung System
- Where
- 18 sites in United States
- Volunteers
- 458 people
- Sponsor
- TransMedics
Liver Transplant
OCS Liver Perfusion (OLP) Post-Approval Registry
The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device…
- Trial name
- NCT05074160
- Testing
- OCS Liver
- Where
- 9 sites in United States
- Volunteers
- 166 people
- Sponsor
- TransMedics
Heart Transplant
OCS Heart EXPAND + CAP Continued Follow-Up
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Heart EXPAND and OCS Heart EXPAND CAP studies.
- Trial name
- NCT05096299
- Testing
- OCS Heart
- Volunteers
- 150 people
- Sponsor
- TransMedics
Liver Transplant
US National OCS Liver Perfusion (OLP) Registry
This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.
- Trial name
- National OLP (NCT05940857)
- Testing
- OCS Liver
- Where
- 22 sites in United States
- Volunteers
- 100,000 people
- Sponsor
- TransMedics