An observational study in Lung Transplantation, sponsored by TransMedics. Active, not recruiting at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by TransMedics · Observational
Single-arm, prospective, multi-center, post-approval U.S. registry
This is an all-comers registry that will enroll:
Enrolled patients will fall into one of the following three possible analysis categories:
Patient enrollment in the TOP Registry will continue until 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.
TransMedics is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System
This is an all-comers registry that will enroll all:
Enrolled patients will fall into one of the following three possible analysis categories:
Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
Device: OCS Lung System
Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
Device: OCS Lung System
All OCS Lung transplanted patients that do not meet any of the above analysis populations.
Device: OCS Lung System
The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions: * Reducing ischemic injury through the use of warm, oxygenated blood based perfusion. * Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients. * Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.
12-month patient and graft survival post double-lung transplant
Primary Effectiveness Endpoint
Time frame: 12 months
Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs
Lung ischemic time
Time frame: 2 hours
Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours)
Primary Graft Dysfunction
Time frame: 0, 24, 48 and 72 hours
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation
Primary Graft Dysfunction
Time frame: 72 hours
Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate
Utilization Rate
Time frame: 1 hour
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation
Primary Graft Dysfunction
Time frame: Within 72 hours post-transplantation
Standard Criteria Lungs - Incidence of PGD3 at T72 hours
Primary Graft Dysfunction
Time frame: 72 hours
Total ischemia and cross-clamp times for 1st and 2nd transplanted lungs
Ischemic and cross-clamp times
Time frame: 2 hours
Kaplan-Meier patient survival estimated at Month 1, 6, 12, 24, 36, 48 and 60
Survival evaluation (K-M)
Time frame: 1,6,12,24,36,48,60 months
Kaplan-Meier BOS-free survival estimated at Month 12, 24, 36, 48 and 60
BOS free survival (K-M)
Time frame: 12,24,36,48,60 months
Kaplan-Meier Freedom from BOS estimated at Month 12, 24, 36, 48 and 60
Freedom from BOS (K-M)
Time frame: 12,24,36,48,60 months
Kaplan-Meier graft survival (freedom from re-transplant/graft failure) at Month 12, 24, 36, 48 and 60
Graft failure
Time frame: 12,24,36,48,60 months
Lung graft-related SAEs through 30 days post-transplant or discharge - Bronchial anastomotic complications; Major pulmonary-related infection
Safety Endpoint
Time frame: 30 days or hospital discharge (whichever is longer)
Survival incidence at 30 days
Safety Endpoint
Time frame: 30 days
Survival incidence at initial transplant surgery hospital discharge, if longer than 30 days.
Safety Endpoint
Time frame: 30 days or hospital discharge (whichever is longer)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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TransMedics