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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861963
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Alexey Voitov, Meshalkin Research Institute of Pathology of Circulation

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 systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)

Condition or disease Intervention/treatment Phase
Pulmonary Atresia With Ventricular Septal Defect Tetralogy of Fallot With Pulmonary Atresia Procedure: Experimental: RVOT reconstruction by femoral allogenic vein valve conduit Procedure: Systemic-to-pulmonary artery shunts Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Femoral Allogenic Vein Valved Conduit for Palliative Repair of Pulmonary Atresia With Ventricular Septal Defect
Actual Study Start Date : May 5, 2016
Actual Primary Completion Date : March 18, 2019
Actual Study Completion Date : November 22, 2019


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".




Primary Outcome Measures :
  1. Growth of pulmonary arteries [ Time Frame: From 6 to 12 months ]
    -Index Nakata ≥ 150 mm/m2


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861963


Locations
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Russian Federation
Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
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Principal Investigator: Alexander Y Omelchenko, PhD Meshalkin Research Institute of Pathology of Circulation
Additional Information:
Publications of Results:
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Responsible Party: Alexey Voitov, MD, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02861963    
Other Study ID Numbers: FAVVC
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alexey Voitov, Meshalkin Research Institute of Pathology of Circulation:
Femoral Allogenic Vein Valve Conduit
Rehabilitation of native pulmonary arteries
Additional relevant MeSH terms:
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Heart Septal Defects
Tetralogy of Fallot
Heart Septal Defects, Ventricular
Pulmonary Atresia
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Vascular Malformations
Heart Valve Diseases