OCS™ Lung TOP Registry For Donor Lungs for Transplantation
Purpose
Single-arm, prospective, multi-center, post-approval U.S. registry
Condition
- Lung Transplantation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Standard Donor Lungs Primary Analysis Population | Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. |
|
Donor Lungs Initially Unacceptable Primary Analysis Pop. | Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. |
|
All Other Enrolled Patients | All OCS Lung transplanted patients that do not meet any of the above analysis populations. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- TransMedics
Detailed 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.