Trials / Completed
CompletedNCT03835754
Heart EXPAND Continued Access Protocol
Heart Expand Continued Access Protocol
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- TransMedics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OCS Heart System | The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment |
Timeline
- Start date
- 2019-04-17
- Primary completion
- 2021-09-15
- Completion
- 2022-08-12
- First posted
- 2019-02-11
- Last updated
- 2025-01-17
- Results posted
- 2025-01-17
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03835754. Inclusion in this directory is not an endorsement.