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

Primary Purpose

Pulmonary Atresia With Ventricular Septal Defect, Tetralogy of Fallot With Pulmonary Atresia

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Experimental: RVOT reconstruction by femoral allogenic vein valve conduit
Systemic-to-pulmonary artery shunts
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Atresia With Ventricular Septal Defect focused on measuring Femoral Allogenic Vein Valve Conduit, Rehabilitation of native pulmonary arteries

Eligibility Criteria

1 Day - 1 Year (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Novosibirsk State Research Institute of Circulation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Right ventricle outflow tract reconstruction

Systemic-to-pulmonary artery shunts

Arm Description

RVOT reconstruction used femoral allogenic vein valve conduit through ventricular fibrillation and without VSD closure

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

Outcomes

Primary Outcome Measures

Growth of pulmonary arteries
-Index Nakata ≥ 150 mm/m2

Secondary Outcome Measures

Number of further re interventions
catheterization balloon plastic of the pulmonary arteries with stenting unification procedures
Complications
pulmonary arteries stenosis Thrombosis Bleeding Death Vein graft dysfunction

Full Information

First Posted
July 7, 2016
Last Updated
June 26, 2020
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02861963
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2016 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atresia With Ventricular Septal Defect, Tetralogy of Fallot With Pulmonary Atresia
Keywords
Femoral Allogenic Vein Valve Conduit, Rehabilitation of native pulmonary arteries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Right ventricle outflow tract reconstruction
Arm Type
Experimental
Arm Description
RVOT reconstruction used femoral allogenic vein valve conduit through ventricular fibrillation and without VSD closure
Arm Title
Systemic-to-pulmonary artery shunts
Arm Type
Active Comparator
Arm Description
systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)
Intervention Type
Procedure
Intervention Name(s)
Experimental: RVOT reconstruction by femoral allogenic vein valve conduit
Intervention Description
Right ventricular outflow tract reconstruction using femoral allogenic vein valve conduit under CPB and induced ventricular fibrillation
Intervention Type
Procedure
Intervention Name(s)
Systemic-to-pulmonary artery shunts
Intervention Description
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 Measure Information:
Title
Growth of pulmonary arteries
Description
-Index Nakata ≥ 150 mm/m2
Time Frame
From 6 to 12 months
Secondary Outcome Measure Information:
Title
Number of further re interventions
Description
catheterization balloon plastic of the pulmonary arteries with stenting unification procedures
Time Frame
1 year
Title
Complications
Description
pulmonary arteries stenosis Thrombosis Bleeding Death Vein graft dysfunction
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Y Omelchenko, PhD
Organizational Affiliation
Meshalkin Research Institute of Pathology of Circulation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novosibirsk State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24418205
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.
Results Reference
result
PubMed Identifier
24686154
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.
Results Reference
result
PubMed Identifier
21958799
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.
Results Reference
result
PubMed Identifier
9485256
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.
Results Reference
result
Links:
URL
http://linkinghub.elsevier.com/retrieve/pii/S0003-4975(13)02368-0
Description
Growth of diminutive central pulmonary arteries after right ventricle to pulmonary artery homograft implantation
URL
https://academic.oup.com/icvts/article-lookup/doi/10.1093/icvts/ivu052
Description
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.
URL
http://linkinghub.elsevier.com/retrieve/pii/S0003-4975(11)01410-X
Description
Side-to-side aorto-GoreTex central shunt warrants central shunt patency and pulmonary arteries growth.
URL
http://linkinghub.elsevier.com/retrieve/pii/S0003-4975(97)01126-0
Description
Side-to-side aorto-Gore-Tex central shunt

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

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