NCT05915299

US National OCS Heart Perfusion (OHP) Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100,000 (estimated)
• Sponsor: TransMedics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.

Detailed description

The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US. The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.

Conditions

• Heart Transplant

Interventions

Type	Name	Description
DEVICE	OCS Heart	The TransMedics® Organ Care System (OCS) Heart System is an FDA approved portable extracorporeal heart perfusion and monitoring system. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.

Timeline

• Start date: 2023-08-25
• Primary completion: 2029-08-31
• Completion: 2033-08-31
• First posted: 2023-06-22
• Last updated: 2025-10-30

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated device study