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Allogeneic Left Atrial and Pulmonary Vein Transplant for Pulmonary Vein Stenosis

NCT03456193 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-11-23

No results posted yet for this study

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.

Conditions

  • Pulmonary Vein Stenosis

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • David Hoganson, MD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03456193 on ClinicalTrials.gov