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
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
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
NCT ID
NCT02861963
First Posted
July 7, 2016
Last Updated
June 26, 2020
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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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