OCS™ Lung TOP Registry For Donor Lungs for Transplantation

TransMedics

Status: Active, not recruiting

Conditions: Lung Transplantation

Treatments: Device: OCS Lung System

Study type: Observational

Funder types: Industry

Identifiers

NCT03639025

OCS-LUN-PAS01

Details and patient eligibility

About

Single-arm, prospective, multi-center, post-approval U.S. registry

Full description

This is an all-comers registry that will enroll:

1. Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
2. Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
3. All donor lungs that were perfused on OCS Lung System.

Enrolled patients will fall into one of the following three possible analysis categories:

1. TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
2. TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
3. All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.

Patient enrollment in the TOP Registry will continue until 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.

Enrollment: 458 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

This is an all-comers registry that will enroll all:

• Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
• Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
• All donor lungs that were perfused on OCS Lung System.

Enrolled patients will fall into one of the following three possible analysis categories:

• TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
• TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
• All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.

Trial design

458 participants in 3 patient groups

Standard Donor Lungs Primary Analysis Population

Description:

Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.

Treatment:

Device: OCS Lung System

Donor Lungs Initially Unacceptable Primary Analysis Pop.

Description:

Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.

Treatment:

Device: OCS Lung System

All Other Enrolled Patients

Description:

All OCS Lung transplanted patients that do not meet any of the above analysis populations.

Treatment:

Device: OCS Lung System