Trials / Recruiting
RecruitingNCT07145515
Enhancing Heart Allograft Function With the OCS Heart System Trial
Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 655 (estimated)
- Sponsor
- TransMedics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OCS Heart | Preservation of donor hearts with OCS Heart System and novel OCS Solution and OCS Functional Enhancer. |
| OTHER | Static Cold Storage (SCS) | Preservation of donor hearts with static cold storage. |
Timeline
- Start date
- 2026-01-01
- Primary completion
- 2027-01-30
- Completion
- 2027-07-30
- First posted
- 2025-08-28
- Last updated
- 2026-01-12
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07145515. Inclusion in this directory is not an endorsement.