OCS™ Lung TOP Registry



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:December 10, 2018
End Date:October 2023
Contact:Mark Macedo
Email:mmacedo@transmedics.com
Phone:9785225091

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The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry - OCS™ Lung TOP PAS Registry

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

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

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
We found this trial at
7
sites
Houston, Texas 77030
Phone: 713-441-5451
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Mauricio Villavicencio, MD
Phone: 617-726-5608
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Boston, MA
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Matthew G Hartwig, MD, MHS
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Stephen Huddleston, MD
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Alexander Krupnick, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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Houston, Texas 77030
Phone: 832-355-3000
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Houston, TX
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Lucien Durham, MD, PhD
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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