Allogeneic Left Atrial and Pulmonary Vein Transplant for Pulmonary Vein Stenosis (NCT03456193) | Clinical Trial Compass
WithdrawnNot Applicable
Allogeneic Left Atrial and Pulmonary Vein Transplant for Pulmonary Vein Stenosis
Stopped: enrollment/ eligibility concerns
United States0Started 2022-09
Plain-language summary
This is a prospective, single center, safety and feasibility trial to evaluate the transplantation of the left atrium and pulmonary veins in patients with pulmonary vein stenosis. Consented patients will be listed for transplantation. Once a suitable donor has been identified, the left atrium, pulmonary veins and complete lung block will be harvested from the donor and transported to Boston Children's Hospital as is the procedure for routine lung transplantation patients. The left atrium and pulmonary veins will be transplanted into the recipient. The recipient will receive the normal immunosuppression protocol used for heart transplantation.
This pilot study will include 5 patients.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.