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NCT Number: NCT05101460

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XVIVO Perfusion System (XPS™) with STEEN Solution™

Device

XVIVO Perfusion System (XPS™) with STEEN Solution™

Primary outcomes

  1. Survival at 1 year post-transplant

    Time frame: 12 months

    Primary effectiveness endpoint

  2. Primary Graft Dysfunction (PGD)

    Time frame: 72 hours

    Rate of Grade 3 Primary Graft Dysfunction (PGD) at 72 hours

Secondary outcomes

  1. Post-transplant survival

    Time frame: 2 years, 3 years, 4 years and 5 years post-transplant

    Survival at 2, 3, 4 and 5 years post-transplant

  2. Pulmonary Function Test (FEV1)

    Time frame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant

    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.

  3. Incidence of Bronchiolitis Obliterans Syndrome (BOS) or Chronic Lung Allograft Dysfunction (CLAD)

    Time frame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant

    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.

  4. Hospitalizations

    Time frame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant

    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

  5. Acute Rejection Episodes

    Time frame: 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant

    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

  6. Karnofsky Performance Status Scale (KPS)/Karnofsky score

    Time frame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant

    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.

  7. Safety Endpoint

    Time frame: 30 days post-transplant

    XPS related SAEs from transplant to 30 days post-transplant or initial hospital stay, whichever is longer

Sponsors and collaborators

Lead sponsor

XVIVO Perfusion

Industry

Registry information

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Nov 1, 2021
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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