Trials / Completed
CompletedNCT03831048
Donors After Circulatory Death Heart Trial
Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- TransMedics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (Standard of Care 1 \[SOC1\] and Standard of Care 2 \[SOC2\] - from both randomized and concurrent control groups), adjusting for differences in risk factors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OCS Heart System | Preserving and assessing donor after circulatory death hearts for transplant |
| OTHER | Cold Storage | Active comparator intervention |
Timeline
- Start date
- 2019-11-26
- Primary completion
- 2021-04-01
- Completion
- 2021-09-28
- First posted
- 2019-02-05
- Last updated
- 2024-05-07
- Results posted
- 2024-05-07
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03831048. Inclusion in this directory is not an endorsement.