Clinical trial NCT02861963: Choice of Palliative Procedures for Pulmonary Atresia With Ventricular Septal Defect Patients
Official title: Femoral Allogenic Vein Valved Conduit for Palliative Repair of Pulmonary Atresia With Ventricular Septal Defect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Atresia With Ventricular Septal Defect
Tetralogy of Fallot With Pulmonary Atresia
Keywords: Femoral Allogenic Vein Valve Conduit
Rehabilitation of native pulmonary arteries
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-08-10
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Eligibility 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).

Primary outcomes:
measure: Growth of pulmonary arteries
timeFrame: From 6 to 12 months
Secondary outcomes:
measure: Number of further re interventions
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Research Institute of Circulation Pathology
Study officials:
affiliation: Meshalkin Research Institute of Pathology of Circulation
name: Alexander Y Omelchenko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hibino N, He D, Yuan F, Yu JH, Jonas R. Growth of diminutive central pulmonary arteries after right ventricle to pulmonary artery homograft implantation. Ann Thorac Surg. 2014 Jun;97(6):2129-33. doi: 10.1016/j.athoracsur.2013.10.046. Epub 2014 Jan 10.
citation: Zheng S, Yang K, Li K, Li S. Establishment of right ventricle-pulmonary artery continuity as the first-stage palliation in older infants with pulmonary atresia with ventricular septal defect may be preferable to use of an arterial shunt. Interact Cardiovasc Thorac Surg. 2014 Jul;19(1):88-94. doi: 10.1093/icvts/ivu052. Epub 2014 Mar 30.
citation: Barozzi L, Brizard CP, Galati JC, Konstantinov IE, Bohuta L, d'Udekem Y. Side-to-side aorto-GoreTex central shunt warrants central shunt patency and pulmonary arteries growth. Ann Thorac Surg. 2011 Oct;92(4):1476-82. doi: 10.1016/j.athoracsur.2011.05.105.
citation: Gates RN, Laks H, Johnson K. Side-to-side aorto-Gore-Tex central shunt. Ann Thorac Surg. 1998 Feb;65(2):515-6. doi: 10.1016/s0003-4975(97)01126-0.