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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-05

Study Completion Date

2019-11-22

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)

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Right ventricle outflow tract reconstruction

RVOT reconstruction used femoral allogenic vein valve conduit through ventricular fibrillation and without VSD closure

Group Type EXPERIMENTAL

Experimental: RVOT reconstruction by femoral allogenic vein valve conduit

Intervention Type PROCEDURE

Right ventricular outflow tract reconstruction using femoral allogenic vein valve conduit under CPB and induced ventricular fibrillation

Systemic-to-pulmonary artery shunts

systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)

Group Type ACTIVE_COMPARATOR

Systemic-to-pulmonary artery shunts

Intervention Type PROCEDURE

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".

Interventions

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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

Intervention Type 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".

Intervention Type PROCEDURE

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

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).

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No