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

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Femoral Allogenic Vein Valved Conduit for Palliative Repair of Pulmonary Atresia With Ventricular Septal Defect

Conditions
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Pulmonary Atresia With Ventricular Septal Defect, Tetralogy of Fallot With Pulmonary Atresia

Intervention / Treatment
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* Procedure: Experimental: RVOT reconstruction by femoral allogenic vein valve conduit
* Procedure: Systemic-to-pulmonary artery shunts


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right ventricle outflow tract reconstruction<br>RVOT reconstruction used femoral allogenic vein valve conduit through ventricular fibrillation and without VSD closure | Procedure: Experimental: RVOT reconstruction by femoral allogenic vein valve conduit<br>* Right ventricular outflow tract reconstruction using femoral allogenic vein valve conduit under CPB and induced ventricular fibrillation<br>|
| Active Comparator: Systemic-to-pulmonary artery shunts<br>systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt) | Procedure: Systemic-to-pulmonary artery shunts<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth of pulmonary arteries | -Index Nakata ≥ 150 mm/m2 | From 6 to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of further re interventions | catheterization balloon plastic of the pulmonary arteries with stenting unification procedures | 1 year | 
| Complications | pulmonary arteries stenosis Thrombosis Bleeding Death Vein graft dysfunction | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral Allogenic Vein Valve Conduit, Rehabilitation of native pulmonary arteries