COMPANY
TransMedics
Timeline
- Trial start Not phased (device or behavioral study): Decreasing Edema With a Novel OCS Solution Trial source ↗
- Trial start Not phased (device or behavioral study): Enhancing Heart Allograft Function With the OCS Heart System Trial source ↗
- Trial start —: US National TOP Registry source ↗
- Trial start —: US National OCS Heart Perfusion (OHP) Registry source ↗
- Trial start —: OCS Liver Perfusion (OLP) Post-Approval Registry source ↗
- Trial start —: US National OCS Liver Perfusion (OLP) Registry source ↗
- Trial start —: OCS Heart Perfusion Post-Approval Registry source ↗
- Trial start Not phased (device or behavioral study): Donor After Circulatory Death Heart CAP Trial source ↗
- Trial start Not phased (device or behavioral study): OCS Liver DCD Trial source ↗
- Trial start Not phased (device or behavioral study): OCS Liver PROTECT Continued Access Protocol source ↗
- Trial start —: OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study source ↗
- Trial start —: OCS DCD Heart + CAP Continued Follow-Up source ↗
- Trial start Not phased (device or behavioral study): Donors After Circulatory Death Heart Trial source ↗
- Trial start —: INSPIRE Continuation Post-Approval Study source ↗
- Trial start Not phased (device or behavioral study): Heart EXPAND Continued Access Protocol source ↗
- Trial start —: OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection source ↗
- Trial start —: OCS™ Lung TOP Registry For Donor Lungs for Transplantation source ↗
- Trial start Not phased (device or behavioral study): OCS Lung System EXPAND II Trial source ↗
- Trial start Not phased (device or behavioral study): Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation source ↗
- Trial start —: OCS Liver PROTECT Continuation Post-Approval Study source ↗
- Trial start Not phased (device or behavioral study): OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation source ↗
- Trial start —: OCS Heart EXPAND + CAP Continued Follow-Up source ↗
- Trial start Not phased (device or behavioral study): International EXPAND Heart Pivotal Trial source ↗
- Trial start Not phased (device or behavioral study): International EXPAND Lung Pivotal Trial source ↗
- Trial start Not phased (device or behavioral study): International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation source ↗
Upcoming milestones
- 2026-10 (ESTIMATED) · · OCS DCD Heart + CAP Continued Follow-Up · NCT05741723
- Jan 30, 2027 (ESTIMATED) · Not phased · Enhancing Heart Allograft Function With the OCS Heart System Trial · NCT07145515
- 2027-12 (ESTIMATED) · Not phased · Decreasing Edema With a Novel OCS Solution Trial · NCT07340710
- Aug 31, 2029 (ESTIMATED) · · US National OCS Heart Perfusion (OHP) Registry · NCT05915299
- 2031-10 (ESTIMATED) · · US National OCS Liver Perfusion (OLP) Registry · NCT05940857
- 2034-11 (ESTIMATED) · · US National TOP Registry · NCT06513091
Clinical trials (lead sponsor) 26
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT05741723 | OCS DCD Heart + CAP Continued Follow-Up | Not listed | Active, not recruiting | Nov 26, 2019 | 2026-10 (estimated) |
| NCT07340710 | Decreasing Edema With a Novel OCS Solution Trial | Not phased (device or behavioral study) | Not yet recruiting | 2026-03 | 2027-12 (estimated) |
| NCT07145515 | Enhancing Heart Allograft Function With the OCS Heart System Trial | Not phased (device or behavioral study) | Recruiting | 2026-01 | Jan 30, 2027 (estimated) |
| NCT05915299 | US National OCS Heart Perfusion (OHP) Registry | Not listed | Recruiting | Aug 25, 2023 | Aug 31, 2029 (estimated) |
| NCT05047068 | OCS Heart Perfusion Post-Approval Registry | Not listed | Active, not recruiting | Sep 13, 2021 | 2025-12 (estimated) |
| NCT04194437 | OCS Liver DCD Trial | Not phased (device or behavioral study) | Terminated | Jul 24, 2020 | Mar 22, 2022 (actual) |
| NCT06513091 | US National TOP Registry | Not listed | Recruiting | Jan 23, 2025 | 2034-11 (estimated) |
| NCT03639025 | OCS™ Lung TOP Registry For Donor Lungs for Transplantation | Not listed | Active, not recruiting | Dec 10, 2018 | Nov 30, 2025 (estimated) |
| NCT05074160 | OCS Liver Perfusion (OLP) Post-Approval Registry | Not listed | Active, not recruiting | Oct 14, 2021 | Mar 22, 2024 (actual) |
| NCT05096299 | OCS Heart EXPAND + CAP Continued Follow-Up | Not listed | Active, not recruiting | Sep 16, 2015 | 2026-08 (estimated) |
| NCT02323321 | International EXPAND Heart Pivotal Trial | Not phased (device or behavioral study) | Completed | Sep 16, 2015 | Apr 25, 2018 (actual) |
| NCT03835754 | Heart EXPAND Continued Access Protocol | Not phased (device or behavioral study) | Completed | Apr 17, 2019 | Sep 15, 2021 (actual) |
| NCT05940857 | US National OCS Liver Perfusion (OLP) Registry | Not listed | Recruiting | Oct 14, 2021 | 2031-10 (estimated) |
| NCT04186221 | OCS Liver PROTECT Continued Access Protocol | Not phased (device or behavioral study) | Completed | Feb 3, 2020 | Feb 2, 2021 (actual) |
| NCT04615182 | Donor After Circulatory Death Heart CAP Trial | Not phased (device or behavioral study) | Completed | Nov 25, 2020 | Dec 21, 2021 (actual) |
| NCT03831048 | Donors After Circulatory Death Heart Trial | Not phased (device or behavioral study) | Completed | Nov 26, 2019 | Apr 1, 2021 (actual) |
| NCT03343535 | OCS Lung System EXPAND II Trial | Not phased (device or behavioral study) | Terminated | Mar 12, 2018 | Aug 27, 2019 (actual) |
| NCT05096741 | OCS Liver PROTECT Continuation Post-Approval Study | Not listed | Completed | Jan 24, 2016 | Nov 5, 2021 (actual) |
| NCT05096754 | OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study | Not listed | Completed | Feb 3, 2020 | Feb 2, 2023 (actual) |
| NCT02522871 | OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation | Not phased (device or behavioral study) | Completed | Jan 24, 2016 | Oct 22, 2019 (actual) |
| NCT01630434 | International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation | Not phased (device or behavioral study) | Completed | 2011-11 | 2014-09 (actual) |
| NCT01963780 | International EXPAND Lung Pivotal Trial | Not phased (device or behavioral study) | Completed | 2013-11 | Nov 22, 2016 (actual) |
| NCT04194398 | OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection | Not listed | Completed | Dec 31, 2018 | Sep 30, 2021 (actual) |
| NCT03868904 | INSPIRE Continuation Post-Approval Study | Not listed | Completed | Jun 30, 2019 | Oct 12, 2021 (actual) |
| NCT00855712 | Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation | Not phased (device or behavioral study) | Completed | 2009-03 | 2013-10 (actual) |
| NCT02449694 | Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation | Not phased (device or behavioral study) | Completed | 2016-05 | Sep 19, 2017 (actual) |