US National TOP Registry
US National OCS Lung Thoracic Organ Perfusion (TOP) Registry
1 other identifier
observational
10,000
1 country
7
Brief Summary
The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2024
CompletedFirst Posted
Study publicly available on registry
July 22, 2024
CompletedStudy Start
First participant enrolled
January 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2039
September 3, 2025
February 1, 2025
9.8 years
July 12, 2024
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
One-year patient and graft survival
Recipients' one-year patient and graft survival rates
1-year post-transplant
Study Arms (2)
OCS Lung Transplant Recipients
The US National TOP Registry will enroll all liver transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry.
Non-OCS Lung Transplant Recipients
Patients transplanted using other preservation modalities for benchmarking clinical outcomes.
Interventions
The TransMedics Organ Care System (OCS) Lung is an FDA approved portable extracorporeal lung perfusion and monitoring system.
Eligibility Criteria
The US National TOP Registry will enroll all lung transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry, as well as patients transplanted using other preservation modalities for benchmarking clinical outcomes.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- TransMedicslead
Study Sites (7)
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Duke University
Durham, North Carolina, 27705, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75246, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2024
First Posted
July 22, 2024
Study Start
January 23, 2025
Primary Completion (Estimated)
November 1, 2034
Study Completion (Estimated)
November 1, 2039
Last Updated
September 3, 2025
Record last verified: 2025-02