Congenital Heart DefectNCT03348397
Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns
An observational study of Congenital Heart Defect and Right Ventricular Outflow Tract Reconstruction, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial summary
Pulmonary homografts are standard substitutes for right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure secondary to early calcifications and shrinking are observed particularly for small sized conduits in younger patients. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Congenital Heart Defect, Right Ventricular Outflow Tract Reconstruction
- What is being tested?
- right ventricular outflow tract reconstruction with contegra and right ventricular outflow tract reconstruction with pulmonary homograft
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2017to 30 Oct 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 Up to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: All patients who underwent a right ventricular outflow tract reconstruction between January 1992 and December 2014 at the Hôpital Universitaire des Enfants Reine Fabiola, Belgium
Who may be able to join
- neonatal patients who had a reconstruction of the right ventricular outflow tract with a pulmonary homograft or a Contegra between January 1992 and December 2014 at HUDERF
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns : Fifteen Years' Experience
Pulmonary homografts are standard substitutes for right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure secondary to early calcifications and shrinking are observed particularly for small sized conduits in younger patients. In neonates, Contegra® 12mm could be a valuable alternative, but conflicting evidence exists. This retrospective study compared the outcome of these two conduits in a newborn population.
- Being tested
- right ventricular outflow tract reconstruction with contegra, right ventricular outflow tract reconstruction with pulmonary 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.
right ventricular outflow tract reconstruction with contegraProcedure or surgery
Contegra pulmonary valved conduit is an animal jugular vein that contains a valve with three leaflets that are similar to a human heart valve.
right ventricular outflow tract reconstruction with pulmonary homograftProcedure or surgery
cryopreserved pulmonary homografts
| Study group | Role | What they receive |
|---|---|---|
| Contegra patients | Not described Receives: Procedure: right ventricular outflow tract reconstruction with contegra | |
| Pulmonary homograft patients | Not described Receives: Procedure: right ventricular outflow tract reconstruction with pulmonary homograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mid term course between pediatric right ventricular outflow tract recontruction with homograft and contegra
Measured: up to 195 months post right ventricular outflow tract recontruction
Secondary outcomes (8)
Proportion of early conduit-related reintervention according to the Nakata index
Measured: up to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention according to the congenital heart defect diagnosis
Measured: up to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with contegra
Measured: up to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with pulmonary homograft
Measured: up to 195 months post right ventricular outflow tract recontruction
Overal mortality in right ventricular outflow tract recontructed with contegra
Measured: up to 195 months post right ventricular outflow tract recontruction
Overal mortality in right ventricular outflow tract recontructed with pulmonary homograft
Measured: up to 195 months post right ventricular outflow tract recontruction
Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with contegra
Measured: up to 195 months post right ventricular outflow tract recontruction
Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with pulmonary homograft
Measured: up to 195 months post right ventricular outflow tract recontruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Mar 2017
- Primary completion1 Jun 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Wauthy, MDPhD, Principal investigator, Queen Fabiola Children's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348397
- Sponsor's protocol ID
- P2016/Cardio/RVOTtherapy
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Falchetti A, Demanet H, Dessy H, Melot C, Pierrakos C, Wauthy P. Contegra versus pulmonary homograft for right ventricular outflow tract reconstruction in newborns. Cardiol Young. 2019 Apr;29(4):505-510. doi: 10.1017/S1047951119000143. Epub 2019 Apr 3.
PubMed 30942148
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns : Fifteen Years' Experience
- ClinicalTrials.gov ID
- NCT03348397
- Acronym / sponsor ID
- P2016/Cardio/RVOTtherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 20 Nov 2017 (actual)
- 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.
Pulmonary homografts are standard substitutes for right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure secondary to early calcifications and shrinking are observed particularly for small sized conduits in younger patients. In neonates, Contegra® 12mm could be a valuable alternative, but conflicting evidence exists. This retrospective study compared the outcome of these two conduits in a newborn population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contegra patients | – | Procedure: right ventricular outflow tract reconstruction with contegra |
| Pulmonary homograft patients | – | Procedure: right ventricular outflow tract reconstruction with pulmonary homograft |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients who underwent a right ventricular outflow tract reconstruction between January 1992 and December 2014 at the Hôpital Universitaire des Enfants Reine Fabiola, Belgium
Key inclusion criteria (1 listed)
- neonatal patients who had a reconstruction of the right ventricular outflow tract with a pulmonary homograft or a Contegra between January 1992 and December 2014 at HUDERF
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| right ventricular outflow tract reconstruction with contegraContegra pulmonary valved conduit is an animal jugular vein that contains a valve with three leaflets that are similar to a human heart valve. | Procedure or surgery | Contegra patients |
| right ventricular outflow tract reconstruction with pulmonary homograftcryopreserved pulmonary homografts | Procedure or surgery | Pulmonary homograft patients |
Primary outcome
Comparison of mid term course between pediatric right ventricular outflow tract recontruction with homograft and contegra
Time frame: up to 195 months post right ventricular outflow tract recontruction
8 secondary outcomes
Proportion of early conduit-related reintervention according to the Nakata index
Time frame: up to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention according to the congenital heart defect diagnosis
Time frame: up to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with contegra
Time frame: up to 195 months post right ventricular outflow tract recontruction
Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with pulmonary homograft
Time frame: up to 195 months post right ventricular outflow tract recontruction
Overal mortality in right ventricular outflow tract recontructed with contegra
Time frame: up to 195 months post right ventricular outflow tract recontruction
Overal mortality in right ventricular outflow tract recontructed with pulmonary homograft
Time frame: up to 195 months post right ventricular outflow tract recontruction
Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with contegra
Time frame: up to 195 months post right ventricular outflow tract recontruction
Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with pulmonary homograft
Time frame: up to 195 months post right ventricular outflow tract recontruction
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 20 Nov 2017.
- Derived from this study: PubMed 30942148Falchetti A, Demanet H, Dessy H, Melot C, Pierrakos C, Wauthy P. Contegra versus pulmonary homograft for right ventricular outflow tract reconstruction in newborns. Cardiol Young. 2019 Apr;29(4):505-510. doi: 10.1017/S1047951119000143. Epub 2019 Apr 3.
- 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.
Pierre Wauthy, MDPhD principal investigator
Queen Fabiola Children's University Hospital
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 Defect and Right Ventricular Outflow Tract Reconstruction, run by Queen Fabiola Children's University Hospital 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 20 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?
Comparison of mid term course between pediatric right ventricular outflow tract recontruction with homograft and contegra (time frame: up to 195 months post right ventricular outflow tract recontruction). 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 NCT03348397, which also lists 1 linked publication.
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 20 Nov 2017.