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

Pulmonary Atresia With Ventricular Septal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861963
• Other study ID #: FAVVC
• Status: Completed
• Phase: N/A
• Start date: May 5, 2016
• Est. completion date: November 22, 2019

Study information

• Verified date: June 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 22, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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).

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Pulmonary Atresia
• Pulmonary Atresia With Ventricular Septal Defect
• Tetralogy of Fallot
• Tetralogy of Fallot With Pulmonary Atresia

Intervention

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
• 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".

Locations

Country	Name	City	State
Russian Federation	Novosibirsk State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (4)

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. — View Citation

Gates RN, Laks H, Johnson K. Side-to-side aorto-Gore-Tex central shunt. Ann Thorac Surg. 1998 Feb;65(2):515-6. — View 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. — View 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 Cardiova — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth of pulmonary arteries	-Index Nakata = 150 mm/m2	From 6 to 12 months
Secondary	Number of further re interventions	catheterization; balloon plastic of the pulmonary arteries with stenting; unification procedures	1 year
Secondary	Complications	pulmonary arteries stenosis; Thrombosis; Bleeding; Death; Vein graft dysfunction	1 year

External Links

•   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.
•   Growth of diminutive central pulmonary arteries after right ventricle to pulmonary artery homograft implantation
•   Side-to-side aorto-Gore-Tex central shunt
•   Side-to-side aorto-GoreTex central shunt warrants central shunt patency and pulmonary arteries growth.