An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant

The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and monitor device-related serious adverse events. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Transplant
• Intervention / Treatment: Device: XVIVO Perfusion System (XPS™) with STEEN Solution™

Detailed Description

The XVIVO registry is an ongoing, observational, multicenter, retrospective review of patients exposed to XPS™ EVLP-treated lungs. The Registry study is aligned and managed by the UNOS and OPTN data collection process. This registry uses quarterly STAR file data requests for the OPTN data managed by UNOS.

The EVLP procedure and transplantation will be performed per XPS™ Instructions for Use and the treating physician's discretion. Post-transplant clinical care will follow the institution's standard-of-care policies.

OPTN updated the data collected since the submission of the protocol therefore the data collection has changed. The following data has updated collection:

• Collects if hospitalized since last follow-up (yes, no), not the number of hospitalizations
• Collects acute rejection episodes (yes treated, yes not treated, no), not the number of episodes
• Collects Karnofsky Score as replacement for Physical and functional capacity
• Employment limitations has been updated to working for income (yes or no)
• No longer collects BOS, XVIVO to request BOS evaluations on subjects with visits prior to June 30, 2020 and any other omissions of end points not available in the data requested via STAR request.
• Collects FEV1 (L) effective June 30, 2020 to calculate CLAD and diagnosis of CLAD, if applicable.
• No longer provides Other, Specify text in STAR request.

• Study Type: Observational
• Enrollment (Estimated): 315

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This is an "All Comers Registry" hence, no specific investigator sites. All patients receiving EVLP lungs treated with XPS™ will be included in the registry without eligibility criteria or pre-selection. Since the registry collects only standard-of-care data and requires no additional procedures or risks to the subject, a waiver of consent is appropriate

Description

This is an "All Comers Registry" hence will include all patients receiving EVLP lungs.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival at 1 year post-transplant	Primary effectiveness endpoint	12 months
Primary Graft Dysfunction (PGD)	Rate of Grade 3 Primary Graft Dysfunction (PGD) at 72 hours	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-transplant survival	Survival at 2, 3, 4 and 5 years post-transplant	2 years, 3 years, 4 years and 5 years post-transplant
Pulmonary Function Test (FEV1)	Pulmonary Function Test (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is the key lung function test in diagnosing BOS. FEV1 test at 1 year, 2 years, 3 years, 4 years and 5 years post-transplant.	1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Hospitalizations	The presence of in-patient hospital admissions between transplant and 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant	1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Acute Rejection Episodes	The presence of biopsy proven hospital admissions between transplant and 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant	1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant
Karnofsky Performance Status Scale (KPS)/Karnofsky score	Karnofsky Performance Status Scale is an assessment tool for functional impairment. It is used to improve understanding of patient needs, ability to carry out daily activities and to assess patient prognosis. Karnofsky score is calculated at 1 year, 2 years, 3 years, 4 years and 5 years post-transplant. Higher the Karnofsky score, better the ability to carry out daily activities.	1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Safety Endpoint	XPS related SAEs from transplant to 30 days post-transplant or initial hospital stay, whichever is longer	30 days post-transplant
Incidence of Bronchiolitis Obliterans Syndrome (BOS) or Chronic Lung Allograft Dysfunction (CLAD)	Rate of Grade 0 through 3 Bronchiolitis Obliterans Syndrome (BOS) at 1 year, 2 years, 3 years, 4 years and 5 years post-transplant. Clinically, BOS is associated with a progressive decline in forced expiratory volume in one second (FEV1) greater than or equal to 20% of baseline. Decline in FEV1 % increases the risk of development of BOS (Grade 0 to 3). CLAD is defined as a substantial and persistent decline (≥ 20%) in measured FEV1 value from the reference (baseline) value after lung transplantation, with or without a change in FVC. If CLAD is identified, staging and phenotype will be assigned.	1 year, 2 years, 3 years, 4 years and 5 years post-transplant

Collaborators and Investigators

• Sponsor: XVIVO Perfusion
• Investigators: Study Director: Sarah Lowe, XVIVO Perfusion

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2019
• Primary Completion (Estimated): April 24, 2029
• Study Completion (Estimated): April 24, 2029

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Lung Transplant; Transplantation lung
• Additional Relevant MeSH Terms: Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Photoelectron Spectroscopy
• Other Study ID Numbers: XVO-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No