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

June 26, 2020 updated by: Alexey Voitov, Meshalkin Research Institute of Pathology of Circulation

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Novosibirsk State Research Institute of Circulation Pathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Right ventricle outflow tract reconstruction
RVOT reconstruction used femoral allogenic vein valve conduit through ventricular fibrillation and without VSD closure
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
Active Comparator: Systemic-to-pulmonary artery shunts
systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)
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".

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of further re interventions
Time Frame: 1 year
  • catheterization
  • balloon plastic of the pulmonary arteries with stenting
  • unification procedures
1 year
Complications
Time Frame: 1 year
  • pulmonary arteries stenosis
  • Thrombosis
  • Bleeding
  • Death
  • Vein graft dysfunction
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

  • Principal Investigator: Alexander Y Omelchenko, PhD, Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2016

Primary Completion (Actual)

March 18, 2019

Study Completion (Actual)

November 22, 2019

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

August 6, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 26, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAVVC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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