US National OCS Heart Perfusion (OHP) Registry

Recruiting

• Conditions: Heart Transplant

• Registration Number: NCT05915299
• Lead Sponsor: TransMedics

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-22
• Study Start: 2023-08-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2029-08-31
• Study Completion: 2033-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

• N/A

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recipients' patient and graft survival	Up to 5 years post-transplant	Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Heart transplanted recipients compared to recipients receiving heart transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database.

Trial Locations

Locations (32)

University of California San Diago; 🇺🇸 La Jolla, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Scroll for more (22 remaining)