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 ]
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