Congenital Hypoplasia of Aortic ArchAortoplastyNCT03588312
Long Term Results in Hypoplastic Aortic Arch Repair in Neonates Using a Glutaraldehyde Treated Autologous Pericardial Patch
An observational study of Congenital Hypoplasia of Aortic Arch, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial summary
Hypoplastic aortic arch is a congenital heart defect that is prejudicial for the growth of newborns. It is often associated to other heart defects. Different surgical techniques exist to address this defect, but the literature is very poor with regards to the use of an autologous pericardial patch. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Congenital Hypoplasia of Aortic Arch
- What is being tested?
- Aortoplasty using autologous pericardial patch
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2018to 1 Sep 2018
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Study population: All newborns treated in Hopital Universitaire Des Enfants - Reine Fabiola (Brussels, Belgium) for a hypoplastic aortic arch and other congenital heart defects.
Who may be able to join
- Newborns with a hypoplastic aortic arch undergoing a first intervention
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020
Pierre Wauthy, MD PhD, 0032 2 4772111, pierre.wauthy@chu-brugmann.be
Pierre Wauthy, MD PhD
About this study
Official title: Retrospective Analysis of Results in Children Treated by an Autologous Pericardial Patch to Repair a Hypoplastic Aortic Arch Associated to Other Congenital Heart Defects
Hypoplastic aortic arch is a congenital heart defect that is prejudicial for the growth of newborns. It is often associated to other heart defects. Different surgical techniques exist to address this defect, but the literature is very poor with regards to the use of an autologous pericardial patch. Most use extensive dissection techniques or synthetic patches. Here investigators report institution's original approach using the newborns own pericardium for what investigators believe to be an optimal correction of the hypoplasia., with preserved growth potential.
Read the detailed description
Retrospective analysis of an already well codified surgical intervention carried out in HUDERF under extra-corporeal circulation
- Conditions
- Congenital Hypoplasia of Aortic Arch
- Being tested
- Aortoplasty using autologous pericardial patch
- Keywords
- Aortic arch hypoplasia, Glutaraldehyde treated autologous pericardium, Single stage repair, Congenital heart defects, Newborns
- 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.
Aortoplasty using autologous pericardial patchProcedure or surgery
hypoplastic aortic arch repair using a glutaraldehyde treated, autologous pericardial patch.
| Study group | Role | What they receive |
|---|---|---|
| simple heart defects | Newborns with hypoplastic aortic arch in simple congenital heart defects requiring aortoplasty Receives: Procedure: Aortoplasty using autologous pericardial patch | |
| complex heart defects. | Newborns with hypoplastic aortic arch in complex congenital heart defects requiring aortoplasty Receives: Procedure: Aortoplasty using autologous pericardial patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 30 days post surgery
Secondary outcomes (1)
Freedom from re-intervention
Measured: Up to 18 years post initial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Jan 2018
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Hypoplasia of Aortic ArchStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588312
- Sponsor's protocol ID
- P2017/Cardio/AorticPlasty
- Acronym
- Aortoplasty
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Results in Children Treated by an Autologous Pericardial Patch to Repair a Hypoplastic Aortic Arch Associated to Other Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT03588312
- Acronym / sponsor ID
- Aortoplasty / P2017/Cardio/AorticPlasty
- Conditions
- Congenital Hypoplasia of Aortic Arch
- Keywords
- Aortic arch hypoplasia, Glutaraldehyde treated autologous pericardium, Single stage repair, Congenital heart defects, Newborns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 17 Jul 2018 (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.
Hypoplastic aortic arch is a congenital heart defect that is prejudicial for the growth of newborns. It is often associated to other heart defects. Different surgical techniques exist to address this defect, but the literature is very poor with regards to the use of an autologous pericardial patch. Most use extensive dissection techniques or synthetic patches. Here investigators report institution's original approach using the newborns own pericardium for what investigators believe to be an optimal correction of the hypoplasia., with preserved growth potential.
Detailed description
Retrospective analysis of an already well codified surgical intervention carried out in HUDERF under extra-corporeal circulation
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simple heart defects | – | Procedure: Aortoplasty using autologous pericardial patchNewborns with hypoplastic aortic arch in simple congenital heart defects requiring aortoplasty |
| complex heart defects. | – | Procedure: Aortoplasty using autologous pericardial patchNewborns with hypoplastic aortic arch in complex congenital heart defects requiring aortoplasty |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All newborns treated in Hopital Universitaire Des Enfants - Reine Fabiola (Brussels, Belgium) for a hypoplastic aortic arch and other congenital heart defects.
Key inclusion criteria (1 listed)
- Newborns with a hypoplastic aortic arch undergoing a first intervention
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 |
|---|---|---|
| Aortoplasty using autologous pericardial patchhypoplastic aortic arch repair using a glutaraldehyde treated, autologous pericardial patch. | Procedure or surgery | complex heart defects., simple heart defects |
Primary outcome
Overall survival
Time frame: 30 days post surgery
1 secondary outcome
Freedom from re-intervention
Time frame: Up to 18 years post initial surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
Related trials for Congenital Hypoplasia of Aortic Arch
Not yet recruiting
Seeking for Perfected Aortic Arch Reconstruction Using a Graphically Designed Patient-specific Surgical Patch
Hypoplastic Left Heart Syndrome (HLHS), Aortic Arch Hypoplasia
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.
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 Hypoplasia of Aortic Arch, 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: status not confirmed, as of the sponsor's last update on 23 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis Chebli, MD (0032 475262210, louis.chebli@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 30 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2018.