Congenital Heart DiseaseNCT03048071
Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position
An observational study of Congenital Heart Disease, run by Pierre Wauthy at 1 site in Belgium.
Trial summary
Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross operation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Data collection within medical files
- How many people
- 84 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Feb 2017to 1 Jun 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients having had the replacement of a Contegra conduct, or the replacement of an homograft in pulmonary position, between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium.
Who may be able to join
- All patients having had the replacement of a Contegra conduct, or the replacement of an homograft in pulmonary position, between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position: a Comparative Study
Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT by valved homografts is since then widely used.Pulmonary and aortic homografts then constituted the gold standard in conduit replacement between the right ventricle and the pulmonary artery (VD-AP).
The increasing demand for homografts currently induces a shortage and unmet demands. This lack of availability, and the durability of homografts in young patients, has encouraged the search for alternative conducts.For example, in 1999, Medtronic® put a bovine jugular vein xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for RVOT reconstruction. This duct naturally has a central valve with three valvules, and there is on both sides of the valve a generous duct length allowing unique adaptation options. This conduit, however, is not perfect.
Whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study is to compare operative morbidity and mortality when replacing Contegra® or homograft.
Read the detailed description
Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT by valved homografts is since then widely used. The technique became particularly popular from the mid-1980s, through the routine use of cryopreservation. Pulmonary and aortic homografts then constituted the gold standard in conduit replacement between the right ventricle and the pulmonary artery (VD-AP). Early failure of homografts is mainly due to early calcifications. Lung homografts are, however, less prone to obstructions and calcifications than aortic homografts but are not readily available, particularly in small sizes (10-18mm).
The increasing demand for homografts currently induces a shortage and unmet demands. This lack of availability, and the durability of homografts in young patients, has encouraged the search for alternative conducts. For example, in 1999, Medtronic® put a bovine jugular vein xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for RVOT reconstruction. This duct naturally has a central valve with three valvules, and there is on both sides of the valve a generous duct length allowing unique adaptation options. It is stored in a glutaraldehyde solution in concentrations sufficient enough to make it non-antigenic, yet low enough to maintain the flexibility of the tissue.This conduit has many advantages: 1) Immediate availability 2) Available size range from 12 to 22mm internal diameter 3) Possibility of adaptation to morphology and easily suturable 4) Good hemodynamics 5) No need for proximal or distal extension 6) lower cost than homograft and 7) non-antigenicity.
This conduit, however, is not perfect. On the one hand, it has no growth potential and therefore risks becoming too small and no longer suitable as the child develops. This problem is particularly encountered in small patients, in whom ducts less than 16mm in diameter have been implanted, and is not specific to the duct in VJB. On the other hand, there is a source of failure specific to the Contegra® prosthesis. These are the stenoses at the level of the distal anastomosis between the duct and the pulmonary artery. Several mechanisms explain this distal stenosis: 1) hypoplasia or distal stenosis of the branches of the pulmonary artery, 2) difference in size between the duct and the pulmonary artery being too important, 3) the surgical technique , 4) immunological and inflammatory reactions, 5) neointimal proliferation, 6) thrombi formation. The most likely cause is multifactorial, with a combination of factors cited above.
Prior et al proposed an operative protocol for reducing the distal stenosis rate. With this protocol distal stenosis has become a rare complication but there are still situations in which the VJB conduit needs to be replaced.
Therefore, whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study is to compare operative morbidity and mortality when replacing Contegra® or homograft.
- Conditions
- Congenital Heart Disease
- Being tested
- Data collection within medical files
- Keywords
- Contegra, Homograft
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection within medical filesOther
Data collection within medical files
| Study group | Role | What they receive |
|---|---|---|
| Homograft in pulmonary position replacement | All patients having had the replacement of an homograft in pulmonary position between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium. Receives: Other: Data collection within medical files | |
| Contegra conduct replacement | All patients having had the replacement of a Contegra conduct between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium. Receives: Other: Data collection within medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age of the child when replacement surgery is performed
Measured: 18 years
Length of time between placement surgery and replacement surgery
Length of time between the placement of the homograft/Contegra and its replacement
Measured: 18 years
Weight
Weight of the child before replacement surgery
Measured: 18 years
Sex
Sex of the child
Measured: 18 years
Homograft/contegra position (anatomic/extra anatomic)
Anatomic or extra anatomic position
Measured: 18 years
Co-intervention (yes/no)
Presence of another surgical intervention during the homograft/contegra replacement surgery
Measured: 18 years
Total duration of intervention
Total duration of the replacement surgery
Measured: 18 years
Total duration of extra corporeal circulation
Total duration of extra corporeal circulation during the replacement surgery
Measured: 18 years
Aortic clampage duration
Total duration of aortic clampage duration during the replacement surgery
Measured: 18 years
Duration of circulatory arrest
Total duration of circulatory arrest during the replacement surgery
Measured: 18 years
Presence of perioperatory complications (yes/no)
Presence of perioperatory complications (yes/no) during the replacement surgery
Measured: 18 years
PRISM Score
Pediatric Risk of Mortality score, ad defined by the pediatric ICU in post-replacement surgery care
Measured: 18 years
Inotropic duration
Inotropic duration in post-replacement surgery care
Measured: 18 years
Extubation day
Number of days between the surgery and the extubation in post-replacement surgery care
Measured: 18 years
Length of stay in ICU
Number of days in ICU after replacement surgery
Measured: 18 years
Length of hospitalisation after replacement surgery
Length of hospitalisation after replacement surgery
Measured: 18 years
Cause of death
Cause of death after replacement surgery
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start14 Feb 2017
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Wauthy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierre Wauthy, Brugmann University Hospital
- Investigators
- Nicolas Poinot, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048071
- Sponsor's protocol ID
- CHUB-Conegra vs homografts
- Status last verified
- Nov 2017
- First submitted
- 2 Feb 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ross DN. Replacement of aortic and mitral valves with a pulmonary autograft. Lancet. 1967 Nov 4;2(7523):956-8. doi: 10.1016/s0140-6736(67)90794-5. No abstract available.
PubMed 4167516Ross DN, Somerville J. Correction of pulmonary atresia with a homograft aortic valve. Lancet. 1966 Dec 31;2(7479):1446-7. doi: 10.1016/s0140-6736(66)90600-3. No abstract available.
PubMed 4163445Boethig D, Goerler H, Westhoff-Bleck M, Ono M, Daiber A, Haverich A, Breymann T. Evaluation of 188 consecutive homografts implanted in pulmonary position after 20 years. Eur J Cardiothorac Surg. 2007 Jul;32(1):133-42. doi: 10.1016/j.ejcts.2007.02.025. Epub 2007 Apr 18.
PubMed 17446081Brown JW, Ruzmetov M, Rodefeld MD, Vijay P, Darragh RK. Valved bovine jugular vein conduits for right ventricular outflow tract reconstruction in children: an attractive alternative to pulmonary homograft. Ann Thorac Surg. 2006 Sep;82(3):909-16. doi: 10.1016/j.athoracsur.2006.03.008.
PubMed 16928507Hickey EJ, McCrindle BW, Blackstone EH, Yeh T Jr, Pigula F, Clarke D, Tchervenkov CI, Hawkins J; CHSS Pulmonary Conduit Working Group. Jugular venous valved conduit (Contegra) matches allograft performance in infant truncus arteriosus repair. Eur J Cardiothorac Surg. 2008 May;33(5):890-8. doi: 10.1016/j.ejcts.2007.12.052. Epub 2008 Mar 4.
PubMed 18313324Corno AF, Hurni M, Griffin H, Galal OM, Payot M, Sekarski N, Tozzi P, von Segesser LK. Bovine jugular vein as right ventricle-to-pulmonary artery valved conduit. J Heart Valve Dis. 2002 Mar;11(2):242-7; discussion 248.
PubMed 12000167Fiore AC, Brown JW, Turrentine MW, Ruzmetov M, Huynh D, Hanley S, Rodefeld MD. A bovine jugular vein conduit: a ten-year bi-institutional experience. Ann Thorac Surg. 2011 Jul;92(1):183-90; discussion 190-2. doi: 10.1016/j.athoracsur.2011.02.073. Epub 2011 May 6.
PubMed 21549348Urso S, Rega F, Meuris B, Gewillig M, Eyskens B, Daenen W, Heying R, Meyns B. The Contegra conduit in the right ventricular outflow tract is an independent risk factor for graft replacement. Eur J Cardiothorac Surg. 2011 Sep;40(3):603-9. doi: 10.1016/j.ejcts.2010.11.081. Epub 2011 Feb 19.
PubMed 21339072Yong MS, Yim D, d'Udekem Y, Brizard CP, Robertson T, Galati JC, Konstantinov IE. Medium-term outcomes of bovine jugular vein graft and homograft conduits in children. ANZ J Surg. 2015 May;85(5):381-5. doi: 10.1111/ans.13018. Epub 2015 Feb 23.
PubMed 25708132Prior N, Alphonso N, Arnold P, Peart I, Thorburn K, Venugopal P, Corno AF. Bovine jugular vein valved conduit: up to 10 years follow-up. J Thorac Cardiovasc Surg. 2011 Apr;141(4):983-7. doi: 10.1016/j.jtcvs.2010.08.037. Epub 2010 Sep 29.
PubMed 20884023Shebani SO, McGuirk S, Baghai M, Stickley J, De Giovanni JV, Bu'lock FA, Barron DJ, Brawn WJ. Right ventricular outflow tract reconstruction using Contegra valved conduit: natural history and conduit performance under pressure. Eur J Cardiothorac Surg. 2006 Mar;29(3):397-405. doi: 10.1016/j.ejcts.2005.11.040. Epub 2006 Jan 24.
PubMed 16439155Holmes AA, Co S, Human DG, Leblanc JG, Campbell AI. The Contegra conduit: Late outcomes in right ventricular outflow tract reconstruction. Ann Pediatr Cardiol. 2012 Jan;5(1):27-33. doi: 10.4103/0974-2069.93706.
PubMed 22529597Corno AF, Mickaily-Huber ES. Comparative computational fluid dynamic study of two distal Contegra conduit anastomoses. Interact Cardiovasc Thorac Surg. 2008 Feb;7(1):1-5. doi: 10.1510/icvts.2007.162412. Epub 2007 Sep 28.
PubMed 17905782Poinot N, Fils JF, Demanet H, Dessy H, Biarent D, Wauthy P. Pulmonary valve replacement after right ventricular outflow tract reconstruction with homograft vs Contegra(R): a case control comparison of mortality and morbidity. J Cardiothorac Surg. 2018 Jan 17;13(1):8. doi: 10.1186/s13019-018-0698-5.
PubMed 29343297
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbimortality of Contegra Duct Replacements Versus Homografts in Pulmonary Position: a Comparative Study
- ClinicalTrials.gov ID
- NCT03048071
- Acronym / sponsor ID
- CHUB-Conegra vs homografts
- Conditions
- Congenital Heart Disease
- Keywords
- Contegra, Homograft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Pierre WauthyUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 9 Feb 2017 (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.
Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT by valved homografts is since then widely used.Pulmonary and aortic homografts then constituted the gold standard in conduit replacement between the right ventricle and the pulmonary artery (VD-AP).
The increasing demand for homografts currently induces a shortage and unmet demands. This lack of availability, and the durability of homografts in young patients, has encouraged the search for alternative conducts.For example, in 1999, Medtronic® put a bovine jugular vein xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for RVOT reconstruction. This duct naturally has a central valve with three valvules, and there is on both sides of the valve a generous duct length allowing unique adaptation options. This conduit, however, is not perfect.
Whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study is to compare operative morbidity and mortality when replacing Contegra® or homograft.
Detailed description
Congenital heart diseases are nowadays frequently treated in newborns. These congenital heart defects can directly affect the right ventricular ejection tract (RVOT), or sometimes indirectly, when the left ventricular ejection tract (LVOT) is replaced by the ROVT in a Ross operation. Originally introduced by Ross and Somerville in 1966, the reconstruction of ROVT by valved homografts is since then widely used. The technique became particularly popular from the mid-1980s, through the routine use of cryopreservation. Pulmonary and aortic homografts then constituted the gold standard in conduit replacement between the right ventricle and the pulmonary artery (VD-AP). Early failure of homografts is mainly due to early calcifications. Lung homografts are, however, less prone to obstructions and calcifications than aortic homografts but are not readily available, particularly in small sizes (10-18mm).
The increasing demand for homografts currently induces a shortage and unmet demands. This lack of availability, and the durability of homografts in young patients, has encouraged the search for alternative conducts. For example, in 1999, Medtronic® put a bovine jugular vein xenograft (VJB) on the market, the Contegra® conduct, as alternative for the homograft for RVOT reconstruction. This duct naturally has a central valve with three valvules, and there is on both sides of the valve a generous duct length allowing unique adaptation options. It is stored in a glutaraldehyde solution in concentrations sufficient enough to make it non-antigenic, yet low enough to maintain the flexibility of the tissue.This conduit has many advantages: 1) Immediate availability 2) Available size range from 12 to 22mm internal diameter 3) Possibility of adaptation to morphology and easily suturable 4) Good hemodynamics 5) No need for proximal or distal extension 6) lower cost than homograft and 7) non-antigenicity.
This conduit, however, is not perfect. On the one hand, it has no growth potential and therefore risks becoming too small and no longer suitable as the child develops. This problem is particularly encountered in small patients, in whom ducts less than 16mm in diameter have been implanted, and is not specific to the duct in VJB. On the other hand, there is a source of failure specific to the Contegra® prosthesis. These are the stenoses at the level of the distal anastomosis between the duct and the pulmonary artery. Several mechanisms explain this distal stenosis: 1) hypoplasia or distal stenosis of the branches of the pulmonary artery, 2) difference in size between the duct and the pulmonary artery being too important, 3) the surgical technique , 4) immunological and inflammatory reactions, 5) neointimal proliferation, 6) thrombi formation. The most likely cause is multifactorial, with a combination of factors cited above.
Prior et al proposed an operative protocol for reducing the distal stenosis rate. With this protocol distal stenosis has become a rare complication but there are still situations in which the VJB conduit needs to be replaced.
Therefore, whether using Contegra® ducts or homografts, replacement is inevitable. The aim of this study is to compare operative morbidity and mortality when replacing Contegra® or homograft.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homograft in pulmonary position replacement | – | Other: Data collection within medical filesAll patients having had the replacement of an homograft in pulmonary position between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium. |
| Contegra conduct replacement | – | Other: Data collection within medical filesAll patients having had the replacement of a Contegra conduct between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients having had the replacement of a Contegra conduct, or the replacement of an homograft in pulmonary position, between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium.
Key inclusion criteria (1 listed)
- All patients having had the replacement of a Contegra conduct, or the replacement of an homograft in pulmonary position, between January 1999 and October 2016, within the Queen Fabiola Children Hospital of Brussels, Belgium.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Data collection within medical filesData collection within medical files | Other | Contegra conduct replacement, Homograft in pulmonary position replacement |
Primary outcome
Age
Time frame: 18 years
Age of the child when replacement surgery is performed
Length of time between placement surgery and replacement surgery
Time frame: 18 years
Length of time between the placement of the homograft/Contegra and its replacement
Weight
Time frame: 18 years
Weight of the child before replacement surgery
Sex
Time frame: 18 years
Sex of the child
Homograft/contegra position (anatomic/extra anatomic)
Time frame: 18 years
Anatomic or extra anatomic position
Co-intervention (yes/no)
Time frame: 18 years
Presence of another surgical intervention during the homograft/contegra replacement surgery
Total duration of intervention
Time frame: 18 years
Total duration of the replacement surgery
Total duration of extra corporeal circulation
Time frame: 18 years
Total duration of extra corporeal circulation during the replacement surgery
Aortic clampage duration
Time frame: 18 years
Total duration of aortic clampage duration during the replacement surgery
Duration of circulatory arrest
Time frame: 18 years
Total duration of circulatory arrest during the replacement surgery
Presence of perioperatory complications (yes/no)
Time frame: 18 years
Presence of perioperatory complications (yes/no) during the replacement surgery
PRISM Score
Time frame: 18 years
Pediatric Risk of Mortality score, ad defined by the pediatric ICU in post-replacement surgery care
Inotropic duration
Time frame: 18 years
Inotropic duration in post-replacement surgery care
Extubation day
Time frame: 18 years
Number of days between the surgery and the extubation in post-replacement surgery care
Length of stay in ICU
Time frame: 18 years
Number of days in ICU after replacement surgery
Length of hospitalisation after replacement surgery
Time frame: 18 years
Length of hospitalisation after replacement surgery
Cause of death
Time frame: 18 years
Cause of death after replacement surgery
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 22 Nov 2017.
- Background: PubMed 4167516Ross DN. Replacement of aortic and mitral valves with a pulmonary autograft. Lancet. 1967 Nov 4;2(7523):956-8. doi: 10.1016/s0140-6736(67)90794-5. No abstract available.
- Background: PubMed 4163445Ross DN, Somerville J. Correction of pulmonary atresia with a homograft aortic valve. Lancet. 1966 Dec 31;2(7479):1446-7. doi: 10.1016/s0140-6736(66)90600-3. No abstract available.
- Background: PubMed 17446081Boethig D, Goerler H, Westhoff-Bleck M, Ono M, Daiber A, Haverich A, Breymann T. Evaluation of 188 consecutive homografts implanted in pulmonary position after 20 years. Eur J Cardiothorac Surg. 2007 Jul;32(1):133-42. doi: 10.1016/j.ejcts.2007.02.025. Epub 2007 Apr 18.
- Background: PubMed 16928507Brown JW, Ruzmetov M, Rodefeld MD, Vijay P, Darragh RK. Valved bovine jugular vein conduits for right ventricular outflow tract reconstruction in children: an attractive alternative to pulmonary homograft. Ann Thorac Surg. 2006 Sep;82(3):909-16. doi: 10.1016/j.athoracsur.2006.03.008.
- Background: PubMed 18313324Hickey EJ, McCrindle BW, Blackstone EH, Yeh T Jr, Pigula F, Clarke D, Tchervenkov CI, Hawkins J; CHSS Pulmonary Conduit Working Group. Jugular venous valved conduit (Contegra) matches allograft performance in infant truncus arteriosus repair. Eur J Cardiothorac Surg. 2008 May;33(5):890-8. doi: 10.1016/j.ejcts.2007.12.052. Epub 2008 Mar 4.
- Background: PubMed 12000167Corno AF, Hurni M, Griffin H, Galal OM, Payot M, Sekarski N, Tozzi P, von Segesser LK. Bovine jugular vein as right ventricle-to-pulmonary artery valved conduit. J Heart Valve Dis. 2002 Mar;11(2):242-7; discussion 248.
- Background: PubMed 21549348Fiore AC, Brown JW, Turrentine MW, Ruzmetov M, Huynh D, Hanley S, Rodefeld MD. A bovine jugular vein conduit: a ten-year bi-institutional experience. Ann Thorac Surg. 2011 Jul;92(1):183-90; discussion 190-2. doi: 10.1016/j.athoracsur.2011.02.073. Epub 2011 May 6.
- Background: PubMed 21339072Urso S, Rega F, Meuris B, Gewillig M, Eyskens B, Daenen W, Heying R, Meyns B. The Contegra conduit in the right ventricular outflow tract is an independent risk factor for graft replacement. Eur J Cardiothorac Surg. 2011 Sep;40(3):603-9. doi: 10.1016/j.ejcts.2010.11.081. Epub 2011 Feb 19.
- Background: PubMed 25708132Yong MS, Yim D, d'Udekem Y, Brizard CP, Robertson T, Galati JC, Konstantinov IE. Medium-term outcomes of bovine jugular vein graft and homograft conduits in children. ANZ J Surg. 2015 May;85(5):381-5. doi: 10.1111/ans.13018. Epub 2015 Feb 23.
- Background: PubMed 20884023Prior N, Alphonso N, Arnold P, Peart I, Thorburn K, Venugopal P, Corno AF. Bovine jugular vein valved conduit: up to 10 years follow-up. J Thorac Cardiovasc Surg. 2011 Apr;141(4):983-7. doi: 10.1016/j.jtcvs.2010.08.037. Epub 2010 Sep 29.
- Background: PubMed 16439155Shebani SO, McGuirk S, Baghai M, Stickley J, De Giovanni JV, Bu'lock FA, Barron DJ, Brawn WJ. Right ventricular outflow tract reconstruction using Contegra valved conduit: natural history and conduit performance under pressure. Eur J Cardiothorac Surg. 2006 Mar;29(3):397-405. doi: 10.1016/j.ejcts.2005.11.040. Epub 2006 Jan 24.
- Background: PubMed 22529597Holmes AA, Co S, Human DG, Leblanc JG, Campbell AI. The Contegra conduit: Late outcomes in right ventricular outflow tract reconstruction. Ann Pediatr Cardiol. 2012 Jan;5(1):27-33. doi: 10.4103/0974-2069.93706.
- 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.
Nicolas Poinot principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Pierre Wauthy at 1 site in Belgium.
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 1 inclusion and 1 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 22 Nov 2017. 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 Belgium. 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?
Age (time frame: 18 years). The study lists 17 primary outcomes in all. 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 NCT03048071, which also lists 14 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 22 Nov 2017.