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

NCT02861963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-06-30

No results posted yet for this study

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)

Conditions

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

Interventions

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".

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Principal Investigators

  • Alexander Y Omelchenko, PhD · Meshalkin Research Institute of Pathology of Circulation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-05
Primary Completion
2019-03-18
Completion
2019-11-22

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02861963 on ClinicalTrials.gov