Status:
SUSPENDED
Allogeneic Left Atrial and Pulmonary Vein Transplant for Pulmonary Vein Stenosis
Lead Sponsor:
Boston Children's Hospital
Conditions:
Pulmonary Vein Stenosis
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief 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 w...
Detailed Description
Techniques for harvest of the posterior left atrium and pulmonary veins from a suitable organ donor have been well established as this is currently accomplished during every harvest of lungs for lung ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03456193
Start Date
September 1 2022
End Date
September 1 2025
Last Update
November 23 2021
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115