Clinical trials: 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
Liver Transplant
OCS Liver DCD Trial
Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.
- Trial name
- NCT04194437
- Testing
- OCS Liver System
- Where
- 4 sites in United States
- Volunteers
- 9 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
Heart Transplant
International EXPAND Heart Pivotal Trial
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve…
- Trial name
- EXPANDHeart (NCT02323321)
- Testing
- Preservation of Hearts for Transplantation
- Where
- 11 sites in United States
- Volunteers
- 75 people
- Sponsor
- TransMedics
Heart Transplant
Heart EXPAND Continued Access Protocol
The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.
- Trial name
- NCT03835754
- Testing
- OCS Heart System
- Where
- 12 sites in United States
- Volunteers
- 75 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
Liver Transplant
OCS Liver PROTECT Continued Access Protocol
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
- Trial name
- NCT04186221
- Testing
- OCS Liver System
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- TransMedics
Heart Transplant
Donor After Circulatory Death Heart CAP Trial
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
- Trial name
- NCT04615182
- Testing
- Transplant
- Where
- 25 sites in United States
- Volunteers
- 90 people
- Sponsor
- TransMedics
Heart Transplant
Donors After Circulatory Death Heart Trial
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.
- Trial name
- NCT03831048
- Testing
- OCS Heart System, Cold Storage
- Where
- 25 sites in United States
- Volunteers
- 180 people
- Sponsor
- TransMedics
Lung Transplantation
OCS Lung System EXPAND II Trial
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
- Trial name
- NCT03343535
- Testing
- OCS Lung Preservation
- Where
- 14 sites in United States
- Volunteers
- 46 people
- Sponsor
- TransMedics
Liver Transplant
OCS Liver PROTECT Continuation Post-Approval Study
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT Trial.
- Trial name
- NCT05096741
- Testing
- OCS Liver
- Where
- 17 sites in United States
- Volunteers
- 300 people
- Sponsor
- TransMedics
Liver Transplant
OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.
- Trial name
- NCT05096754
- Testing
- OCS Liver
- Where
- 11 sites in United States
- Volunteers
- 74 people
- Sponsor
- TransMedics
Liver Transplantation, Liver Preservation for Transplant
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
- Trial name
- PROTECT (NCT02522871)
- Testing
- OCS™ Liver System, Control
- Where
- 20 sites in United States
- Volunteers
- 300 people
- Sponsor
- TransMedics