Pulmonary Atresia With Ventricular Septal DefectNCT02861963
Choice of Palliative Procedures for Pulmonary Atresia With Ventricular Septal Defect Patients
A study testing Experimental: RVOT reconstruction by femoral allogenic vein valve conduit and Systemic-to-pulmonary artery shunts in people with Pulmonary Atresia With Ventricular Septal Defect and Tetralogy of Fallot With Pulmonary Atresia, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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) Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Pulmonary Atresia With Ventricular Septal Defect, Tetralogy of Fallot With Pulmonary Atresia
- What is being tested?
- Experimental: RVOT reconstruction by femoral allogenic vein valve conduit and Systemic-to-pulmonary artery shunts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- 5 May 2016to 22 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 12Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, 630055
About this study
Official title: Femoral Allogenic Vein Valved Conduit for Palliative Repair of Pulmonary Atresia With Ventricular Septal Defect
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)
Read the 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.
- Conditions
- Pulmonary Atresia With Ventricular Septal Defect, Tetralogy of Fallot With Pulmonary Atresia
- Being tested
- Experimental: RVOT reconstruction by femoral allogenic vein valve conduit, Systemic-to-pulmonary artery shunts
- Keywords
- Femoral Allogenic Vein Valve Conduit, Rehabilitation of native pulmonary arteries
- Medical subject headings
- Pulmonary Atresia With Ventricular Septal Defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: RVOT reconstruction by femoral allogenic vein valve conduitProcedure or surgery
Right ventricular outflow tract reconstruction using femoral allogenic vein valve conduit under CPB and induced ventricular fibrillation
Systemic-to-pulmonary artery shuntsProcedure or surgery
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".
| Study group | Role | What they receive |
|---|---|---|
| Right ventricle outflow tract reconstruction | Experimental | RVOT reconstruction used femoral allogenic vein valve conduit through ventricular fibrillation and without VSD closure Receives: 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) Receives: Procedure: Systemic-to-pulmonary artery shunts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth of pulmonary arteries
-Index Nakata ≥ 150 mm/m2
Measured: From 6 to 12 months
Secondary outcomes (2)
Number of further re interventions
- catheterization
- balloon plastic of the pulmonary arteries with stenting
- unification procedures
Measured: 1 year
Complications
- pulmonary arteries stenosis
- Thrombosis
- Bleeding
- Death
- Vein graft dysfunction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start5 May 2016
- Primary completion18 Mar 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Atresia With Ventricular Septal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Alexey Voitov, Meshalkin Research Institute of Pathology of Circulation
- Investigators
- Alexander Y Omelchenko, PhD, Principal investigator, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861963
- Sponsor's protocol ID
- FAVVC
- Status last verified
- Jun 2020
- First submitted
- 7 Jul 2016
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24418205Zheng 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.
PubMed 24686154Barozzi 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.
PubMed 21958799Gates 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.
PubMed 9485256
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Allogenic Vein Valved Conduit for Palliative Repair of Pulmonary Atresia With Ventricular Septal Defect
- ClinicalTrials.gov ID
- NCT02861963
- Acronym / sponsor ID
- FAVVC
- Conditions
- Pulmonary Atresia With Ventricular Septal Defect, Tetralogy of Fallot With Pulmonary Atresia
- Keywords
- Femoral Allogenic Vein Valve Conduit, Rehabilitation of native pulmonary arteries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 5 May 2016 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right ventricle outflow tract reconstruction | Experimental | Procedure: Experimental: RVOT reconstruction by femoral allogenic vein valve conduitRVOT reconstruction used femoral allogenic vein valve conduit through ventricular fibrillation and without VSD closure |
| Systemic-to-pulmonary artery shunts | Active comparator | Procedure: Systemic-to-pulmonary artery shuntssystemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt) |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
- Discordant atrioventricular and/or discordant ventriculo-arterial connections
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: RVOT reconstruction by femoral allogenic vein valve conduitRight ventricular outflow tract reconstruction using femoral allogenic vein valve conduit under CPB and induced ventricular fibrillation | Procedure or surgery | Right ventricle outflow tract reconstruction |
| Systemic-to-pulmonary artery shuntsModified Blalock-Taussig shunt performed between the right subclavian and pulmonary arteries or the left subclavian and pulmonary arteries of the type "end to side". | Procedure or surgery | Systemic-to-pulmonary artery shunts |
Primary outcome
Growth of pulmonary arteries
Time frame: From 6 to 12 months
-Index Nakata ≥ 150 mm/m2
2 secondary outcomes
Number of further re interventions
Time frame: 1 year
Complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Results publication: PubMed 24418205Hibino 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 publication: PubMed 24686154Zheng 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 publication: PubMed 21958799Barozzi 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 publication: PubMed 9485256Gates 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.
- Growth of diminutive central pulmonary arteries after right ventricle to pulmonary artery homograft implantationLink provided by the sponsor.
- Side-to-side aorto-GoreTex central shunt warrants central shunt patency and pulmonary arteries growth.Link provided by the sponsor.
- Side-to-side aorto-Gore-Tex central shuntLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Y Omelchenko, PhD principal investigator
Meshalkin Research Institute of Pathology of Circulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: RVOT reconstruction by femoral allogenic vein valve conduit and Systemic-to-pulmonary artery shunts in people with Pulmonary Atresia With Ventricular Septal Defect and Tetralogy of Fallot With Pulmonary Atresia, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth of pulmonary arteries (time frame: From 6 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02861963, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.