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OpenTrials
Completed

NCT Number: NCT02861963

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

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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Key information

Conditions

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

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Experimental: RVOT reconstruction by femoral allogenic vein valve conduit

Procedure

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

Systemic-to-pulmonary artery shunts

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".

Primary outcomes

  1. Growth of pulmonary arteries

    Time frame: From 6 to 12 months

    -Index Nakata ≥ 150 mm/m2

Secondary outcomes

  1. Number of further re interventions

    Time frame: 1 year

    • catheterization
    • balloon plastic of the pulmonary arteries with stenting
    • unification procedures

  2. Complications

    Time frame: 1 year

    • pulmonary arteries stenosis
    • Thrombosis
    • Bleeding
    • Death
    • Vein graft dysfunction

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2016
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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