Trials / Completed
CompletedNCT04615182
Donor After Circulatory Death Heart CAP Trial
The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- TransMedics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Detailed description
To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transplant | To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance 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. |
Timeline
- Start date
- 2020-11-25
- Primary completion
- 2021-12-21
- Completion
- 2022-06-29
- First posted
- 2020-11-04
- Last updated
- 2024-06-21
- Results posted
- 2024-06-21
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04615182. Inclusion in this directory is not an endorsement.