Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


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

- Consented patients who receive OCS™ preserved double lung transplants from either
standard criteria donors or donors initially deemed unacceptable; and

- Consented 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 the first 289
eligible/PAS consented 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 the first 266 eligible/PAS
consented 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

ArmDescriptionAssigned Intervention
Standard Donor Lungs Primary Analysis Population The first 289 eligible/PAS consented recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
  • 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.
Initially Unacceptable Donor Lung Primary Analysis Pop. The first 266 eligible/PAS consented recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
  • 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.
All Other Enrolled Patients 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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Mauricio Villavicencio, MD
617-726-5608
MVillavicencio@mgh.harvard.edu

More Details

NCT ID
NCT03639025
Status
Recruiting
Sponsor
TransMedics

Study Contact

Mark Macedo
9785225091
mmacedo@transmedics.com

Detailed Description

This is an all-comers registry that will enroll:

1. Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and

2. Consented 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 the first 289 eligible/PAS consented 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 the first 266 eligible/PAS consented 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 both the 289 Primary Analysis Population for OCS-preserved standard criteria donor lungs and 266 Primary Analysis Population for OCS-preserved donor lungs initially deemed unacceptable have been completed.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.