Trials / Completed
CompletedNCT02323321
International EXPAND Heart Pivotal Trial
International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- TransMedics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 donor heart utilization for transplantation
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Preservation of Hearts for Transplantation | Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation |
Timeline
- Start date
- 2015-09-16
- Primary completion
- 2018-04-25
- Completion
- 2019-03-02
- First posted
- 2014-12-23
- Last updated
- 2025-01-17
- Results posted
- 2025-01-17
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02323321. Inclusion in this directory is not an endorsement.