Allogeneic Left Atrial and Pulmonary Vein Transplant for Pulmonary Vein Stenosis

NCT03456193 | Suspended DMC

• 1 other identifier: IRB-P00023581
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Vein Stenosis

Outcome Measures

Primary Outcomes (1)

• Short term survival

  Mortality rate at 30 days following transplantation.

  30 days

Secondary Outcomes (4)

• Pulmonary vein patency

  30 days

• Long term survival

  6 months

• Long term pulmonary vein patency and gradient

  6 months

• Right ventricular pressure

  6 months

Study Arms (1)

LA transplantation

EXPERIMENTAL

The left atrium and pulmonary veins will be transplanted into the recipient

Procedure: LA transplant

Interventions

LA transplant PROCEDURE

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.

LA transplantation

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• Devaney EJ, Chang AC, Ohye RG, Bove EL. Management of congenital and acquired pulmonary vein stenosis. Ann Thorac Surg. 2006 Mar;81(3):992-5; discussion 995-6. doi: 10.1016/j.athoracsur.2005.08.020.

  PMID: 16488708 BACKGROUND

• Yun TJ, Coles JG, Konstantinov IE, Al-Radi OO, Wald RM, Guerra V, de Oliveira NC, Van Arsdell GS, Williams WG, Smallhorn J, Caldarone CA. Conventional and sutureless techniques for management of the pulmonary veins: Evolution of indications from postrepair pulmonary vein stenosis to primary pulmonary vein anomalies. J Thorac Cardiovasc Surg. 2005 Jan;129(1):167-74. doi: 10.1016/j.jtcvs.2004.08.043.

  PMID: 15632839 BACKGROUND

• Bharat A, Epstein DJ, Grady M, Faro A, Michelson P, Sweet SC, Huddleston CB. Lung transplant is a viable treatment option for patients with congenital and acquired pulmonary vein stenosis. J Heart Lung Transplant. 2013 Jun;32(6):621-5. doi: 10.1016/j.healun.2013.03.002.

  PMID: 23701851 BACKGROUND

• Sadr IM, Tan PE, Kieran MW, Jenkins KJ. Mechanism of pulmonary vein stenosis in infants with normally connected veins. Am J Cardiol. 2000 Sep 1;86(5):577-9, A10. doi: 10.1016/s0002-9149(00)01022-5.

  PMID: 11009286 BACKGROUND

MeSH Terms

Conditions

Stenosis, Pulmonary Vein

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Hoganson, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Cardiac surgery

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 7, 2018
• Study Start: September 1, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

US (1)