Choice of Palliative Procedures for Pulmonary Atresia With Ventricular Septal Defect Patients

Overview

The aim is to compare effective growth true hypoplastic pulmonary arteries using Right Ventricle Outflow Tract Reconstruction by femoral allogenic vein valve conduit and systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)

Full Title of Study: “Femoral Allogenic Vein Valved Conduit for Palliative Repair of Pulmonary Atresia With Ventricular Septal Defect”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 18, 2019

Detailed Description

The use of femoral allogenic vein valve conduit for Right Ventricle Outflow Tract Reconstruction is good alternative systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt). Main advantages is straight, symmetrical, pulsating, systolic blood flow in hypoplastic pulmonary artery, which stimulate growth and prepares for a radical repair. Taking into account the absence randomized studies in this area of medicine, providing investigation evaluating parameters of safety for both methodics is very actual.

Interventions

  • Procedure: Experimental: RVOT reconstruction by femoral allogenic vein valve conduit
    • Right ventricular outflow tract reconstruction using femoral allogenic vein valve conduit under CPB and induced ventricular fibrillation
  • Procedure: Systemic-to-pulmonary artery shunts
    • Modified Blalock-Taussig shunt performed between the right subclavian and pulmonary arteries or the left subclavian and pulmonary arteries of the type “end to side”.

Arms, Groups and Cohorts

  • Experimental: Right ventricle outflow tract reconstruction
    • RVOT reconstruction used femoral allogenic vein valve conduit through ventricular fibrillation and without VSD closure
  • Active Comparator: Systemic-to-pulmonary artery shunts
    • systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)

Clinical Trial Outcome Measures

Primary Measures

  • Growth of pulmonary arteries
    • Time Frame: From 6 to 12 months
    • -Index Nakata ≥ 150 mm/m2

Secondary Measures

  • Number of further re interventions
    • Time Frame: 1 year
    • catheterization balloon plastic of the pulmonary arteries with stenting unification procedures
  • Complications
    • Time Frame: 1 year
    • pulmonary arteries stenosis Thrombosis Bleeding Death Vein graft dysfunction

Participating in This Clinical Trial

Inclusion criteria Patients who met the following criteria were included:

  • Patients with PA-VSD type A and B (by Tchervenkov) scheduled for palliative surgery – Age less than one year – Confluent pulmonary artery – Nakata Index ≤ 120 mm2/m2. Exclusion criteria Patients who met any of the following criteria were excluded: – Discordant atrioventricular and/or discordant ventriculo-arterial connections – Concomitant pathology (pneumonia, brain damage, or enterocolitis) – Genetic syndromes (DiGeorge, Alagille, VACTER, CHARGE) – Scheduled MAPCA unifocalisation – Anomalous coronary arteries – Other surgical approaches (complete primary repair, primary unification of pulmonary blood flow, stenting RVOT, or patent ductus arteriosus, radiofrequency pulmonary valve perforation).

Gender Eligibility: All

Minimum Age: 1 Day

Maximum Age: 1 Year

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Meshalkin Research Institute of Pathology of Circulation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alexey Voitov, MD – Meshalkin Research Institute of Pathology of Circulation
  • Overall Official(s)
    • Alexander Y Omelchenko, PhD, Principal Investigator, Meshalkin Research Institute of Pathology of Circulation

Citations Reporting on Results

Hibino N, He D, Yuan F, Yu JH, Jonas R. Growth of diminutive central pulmonary arteries after right ventricle to pulmonary artery homograft implantation. Ann Thorac Surg. 2014 Jun;97(6):2129-33. doi: 10.1016/j.athoracsur.2013.10.046. Epub 2014 Jan 10.

Zheng S, Yang K, Li K, Li S. Establishment of right ventricle-pulmonary artery continuity as the first-stage palliation in older infants with pulmonary atresia with ventricular septal defect may be preferable to use of an arterial shunt. Interact Cardiovasc Thorac Surg. 2014 Jul;19(1):88-94. doi: 10.1093/icvts/ivu052. Epub 2014 Mar 30.

Barozzi L, Brizard CP, Galati JC, Konstantinov IE, Bohuta L, d'Udekem Y. Side-to-side aorto-GoreTex central shunt warrants central shunt patency and pulmonary arteries growth. Ann Thorac Surg. 2011 Oct;92(4):1476-82. doi: 10.1016/j.athoracsur.2011.05.105.

Gates RN, Laks H, Johnson K. Side-to-side aorto-Gore-Tex central shunt. Ann Thorac Surg. 1998 Feb;65(2):515-6. doi: 10.1016/s0003-4975(97)01126-0.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.