NCT02861963

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

2.9 years

First QC Date

July 7, 2016

Last Update Submit

June 26, 2020

Conditions

Pulmonary Atresia With Ventricular Septal DefectTetralogy of Fallot With Pulmonary Atresia

Keywords

Femoral Allogenic Vein Valve ConduitRehabilitation of native pulmonary arteries

Outcome Measures

Primary Outcomes (1)

  • Growth of pulmonary arteries

    -Index Nakata ≥ 150 mm/m2

    From 6 to 12 months

Secondary Outcomes (2)

  • Number of further re interventions

    1 year

  • Complications

    1 year

Study Arms (2)

Right ventricle outflow tract reconstruction

EXPERIMENTAL

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

Systemic-to-pulmonary artery shunts

ACTIVE COMPARATOR

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

Procedure: Systemic-to-pulmonary artery shunts

Interventions

Experimental: RVOT reconstruction by femoral allogenic vein valve conduitPROCEDURE

Right ventricular outflow tract reconstruction using femoral allogenic vein valve conduit under CPB and induced ventricular fibrillation

Right ventricle outflow tract reconstruction
Systemic-to-pulmonary artery shuntsPROCEDURE

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".

Systemic-to-pulmonary artery shunts

Eligibility Criteria

Age1 Day - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Related Publications (4)

  • 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.

    PMID: 24418205RESULT

  • 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.

    PMID: 24686154RESULT

  • 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.

    PMID: 21958799RESULT

  • 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.

    PMID: 9485256RESULT

Related Links

MeSH Terms

Conditions

Pulmonary Atresia With Ventricular Septal Defect

Study Officials

  • Alexander Y Omelchenko, PhD

    Meshalkin Research Institute of Pathology of Circulation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 7, 2016

First Posted

August 10, 2016

Study Start

May 5, 2016

Primary Completion

March 18, 2019

Study Completion

November 22, 2019

Last Updated

June 30, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)