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

Inclusion Criteria

(Donor):

- Donor age < 65 years old.

- Normal gas exchange PaO2/FiO2 ratio ≥ 300 mmHg at final acceptance of donor lungs

Exclusion Criteria

(Donor):

- Positive serology (Hepatitis B, Hepatitis C, HIV)

- Presence of moderate to severe traumatic donor lung injury such as: pneumo/hemothorax or lung contusion seen on chest X-ray, CT scan, visual inspection, or bronchoscopy

- Presence of active pneumonia or lung infection, or structural lung disease (e.g., masses, COPD bullae, or infarcts)

- Donor after circulatory death (DCD donor)

Inclusion Criteria (Recipient)

- Male or female primary double-lung transplant candidate who receives a standard criteria donor lung perfused on the OCS™

- Age ≥ 18 years old

- Signed: written informed consent and authorization to access and disclose protected health information

Exclusion Criteria (Recipient)

- Single lung transplant recipient

- Prior solid organ or bone marrow transplant

- Multi-organ transplant recipient

- Chronic use of hemodialysis or diagnosis of chronic renal failure requiring dialysis

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

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 minimum of 500 double lung transplant recipients transplanted with donor lungs preserved using the OCS™ Lung System. All consented subjects who receive OCS™-preserved double lung transplants will be approached for participation. When a matching donor lung is identified for a PAS consented recipient, it will be evaluated for eligibility. The registry will evaluate short and long-term safety and effectiveness of the OCS™ Lung System for lung transplantation in a real-world environment

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.