US National TOP Registry

TransMedics

Status: Enrolling

Conditions: Lung Transplant

Treatments: Device: OCS Lung

Study type: Observational

Funder types: Industry

Identifiers

NCT06513091

OCS-LUN-TOP-II

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All lung transplant recipients

Trial design

10,000 participants in 2 patient groups

OCS Lung Transplant Recipients

Description:

The US National TOP Registry will enroll all liver transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry.

Treatment:

Device: OCS Lung

Non-OCS Lung Transplant Recipients

Description:

Patients transplanted using other preservation modalities for benchmarking clinical outcomes.