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Allogeneic Left Atrial and Pulmonary Vein Transplant for Pulmonary Vein Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456193
Recruitment Status : Suspended (reviewing eligibility criteria)
First Posted : March 7, 2018
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
David Hoganson, Boston Children's Hospital

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 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.


Condition or disease Intervention/treatment Phase
Pulmonary Vein Stenosis Procedure: LA transplant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Left Atrial and Pulmonary Vein Transplant for Pulmonary Vein Stenosis
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LA transplantation
The left atrium and pulmonary veins will be transplanted into the recipient
Procedure: LA transplant

The proposed study treatment will include three central components:

  • Harvest of the left atrium and pulmonary veins from a suitable donor
  • Excision of the left atrium and portions of stenotic pulmonary veins from the patient with pulmonary vein stenosis
  • Implantation of the donor posterior left atrium and portions of pulmonary veins into the patient.




Primary Outcome Measures :
  1. Short term survival [ Time Frame: 30 days ]
    Mortality rate at 30 days following transplantation.


Secondary Outcome Measures :
  1. Pulmonary vein patency [ Time Frame: 30 days ]
    The study team will assess for the flow through the transplanted pulmonary veins.

  2. Long term survival [ Time Frame: 6 months ]
    Mortality rate at 6 months following transplantation.

  3. Long term pulmonary vein patency and gradient [ Time Frame: 6 months ]
    The study team will assess for the flow through the transplanted pulmonary veins and any increased gradient through the transplanted pulmonary veins (gradient through transplanted veins that has been deemed greater than mild).

  4. Right ventricular pressure [ Time Frame: 6 months ]
    The study team will assess for any increase in right ventricular pressure and/or concerns for developing pulmonary hypertension.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456193


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: David Hoganson, MD Boston Children's Hospital
Publications:
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Responsible Party: David Hoganson, Instructor in Cardiac surgery, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03456193    
Other Study ID Numbers: IRB-P00023581
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stenosis, Pulmonary Vein
Constriction, Pathologic
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases