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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02861963

Enrollment

Registered

2016-08-10

Start date

2016-05-05

Completion date

2019-11-22

Last updated

2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Femoral Allogenic Vein Valve Conduit, Rehabilitation of native pulmonary arteries

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.

Interventions

PROCEDUREExperimental: 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

PROCEDURESystemic-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 1 Years

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026