Clinical trial NCT05101460: An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
Official title: An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Transplant
Keywords: Lung Transplant; Transplantation lung
Lead sponsor: XVIVO Perfusion
Sponsor class: INDUSTRY
First posted: 2021-11-01
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

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

Primary outcomes:
measure: Survival at 1 year post-transplant
timeFrame: 12 months
measure: Primary Graft Dysfunction (PGD)
timeFrame: 72 hours
Secondary outcomes:
measure: Post-transplant survival
timeFrame: 2 years, 3 years, 4 years and 5 years post-transplant
measure: Pulmonary Function Test (FEV1)
timeFrame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
measure: Incidence of Bronchiolitis Obliterans Syndrome (BOS) or Chronic Lung Allograft Dysfunction (CLAD)
timeFrame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
measure: Hospitalizations
timeFrame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
measure: Acute Rejection Episodes
timeFrame: 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant
measure: Karnofsky Performance Status Scale (KPS)/Karnofsky score
timeFrame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
measure: Safety Endpoint
timeFrame: 30 days post-transplant
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: XVIVO Perfusion Inc.
name: Jaya Tiwari, BS, CCRP
role: STUDY_DIRECTOR
References: