Rare lung vein condition targeted by novel transplant trial
NCT ID NCT03456193
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study planned to test a new surgical approach for people with pulmonary vein stenosis, a condition where the veins carrying blood from the lungs to the heart become narrowed. The procedure involved transplanting a donor's left atrium and pulmonary veins, followed by lifelong immunosuppression to prevent rejection. The trial was withdrawn before enrolling any participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
-
Sep 2022
An estimate. Start dates often move.
- Expected to finish
-
Sep 2025
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Up to 17 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pulmonary vein stenosis involving at least one but up to all of the main pulmonary veins following initial treatment, including but not limited to balloon dilation, stenting, surgical repair or chemotherapy * Focal pulmonary stenosis limited to the main pulmonary veins or their first or second order branches. Exclusion Criteria: * Diffuse pulmonary vein stenosis involving long segments of one or more pulmonary veins including diffuse stenosis into the second order pulmonary vein branches or beyond * Significant underlying lung disease * Irreversible pulmonary artery hypertension exceeding indexed 10 Woods units (WU) * Irreversible multisystem organ failure; or additive effects of multiple systems affected making transplant survival unlikely * Progressive systemic disease with early mortality (genetic/metabolic, idiopathic, syndromic) * Morbid obesity (BMI\>30) * Diabetes mellitus with evidence of end-organ damage * Severe chromosomal, neurologic or syndromic abnormalities * Active infection * HIV or chronic hepatitis B or C infection * Severe left ventricular dysfunction * Malignancy within 5 years prior to transplant * Severe renal or liver failure * Inadequate social support for post-transplant management * Recent history of illicit drug, tobacco or alcohol abuse despite trials/assistance to stop behavior * Episode of acute rejection within the previous 6 months * Post-transplant lymphoproliferative disease that has been within two years * Evidence of large stroke with high risk for hemorrhagic conversion
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pulmonary vein stenosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.