NCT02861963

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 1 Day – 1 Year
• Healthy volunteers: Not accepted

Summary

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

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

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

Interventions

Type	Name	Description
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".

Timeline

• Start date: 2016-05-05
• Primary completion: 2019-03-18
• Completion: 2019-11-22
• First posted: 2016-08-10
• Last updated: 2020-06-30

Locations

1 site across 1 country: Russia