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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 modified Blalock-Taussig shunt

Detailed Summary: The use of femoral allogenic vein valve conduit for Right Ventricle Outflow Tract Reconstruction is good alternative 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.
Sponsor: Meshalkin Research Institute of Pathology of Circulation

Current Primary Outcome: Growth of pulmonary arteries [ Time Frame: From 6 to 12 months ]

-Index Nakata ≥ 150 mm/m2


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Meshalkin Research Institute of Pathology of Circulation

Dates:
Date Received: July 7, 2016
Date Started: June 2016
Date Completion: December 2018
Last Updated: August 6, 2016
Last Verified: August 2016