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

Not Applicable

Completed

• Conditions: Pulmonary Atresia With Ventricular Septal Defect; Tetralogy of Fallot With Pulmonary Atresia
• Interventions: Procedure: Systemic-to-pulmonary artery shunts

• Registration Number: NCT02861963
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief 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.

Study Timeline

• Study Start: 2016-05-05
• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-08-06
• Study First Posted: 2016-08-10
• Primary Completion: 2019-03-18
• Study Completion: 2019-11-22
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systemic-to-pulmonary artery shunts	Systemic-to-pulmonary artery shunts	systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)

Primary Outcome Measures

Name	Time	Method
Growth of pulmonary arteries	From 6 to 12 months	-Index Nakata ≥ 150 mm/m2

Secondary Outcome Measures

Name	Time	Method
Number of further re interventions	1 year	* catheterization; * balloon plastic of the pulmonary arteries with stenting; * unification procedures
Complications	1 year	* pulmonary arteries stenosis; * Thrombosis; * Bleeding; * Death; * Vein graft dysfunction

Trial Locations

Locations (1)

Novosibirsk State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation