Isolated Right Aortic ArchARCADENCT04029064
Management of Prenatally Diagnosed Isolated Right Aortic Arch
An observational study of Isolated Right Aortic Arch, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The existence of a right aortic arch integrates nosologically into the group of aortic vascular arch anomalies. In the majority of cases, a right aortic arch is associated with cono-truncal congenital heart diseases (CHD), such as tetralogy of Fallot, pulmonary atresia with ventricular septal defect, and truncus… Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Isolated Right Aortic Arch
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 31 Dec 2019
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Children with antenatal diagnosis of isolated right aortic arch
Who may be able to join
- Prenatal diagnosis of an isolated right aortic arch
Who cannot join
- Association with any congenital heart disease according to the ACC-CHD (Orphanet) classification
- Postnatal diagnosis of an isolated right aortic arch
- Refusal of parents to use medical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Prenatally Diagnosed Isolated Right Aortic Arch: the ARCADE Study
The existence of a right aortic arch integrates nosologically into the group of aortic vascular arch anomalies. In the majority of cases, a right aortic arch is associated with cono-truncal congenital heart diseases (CHD), such as tetralogy of Fallot, pulmonary atresia with ventricular septal defect, and truncus arteriosus. Sometimes, a right aortic arch can be isolated, with an incidence of 0.05% to 0.1 %. Therefore, an assessment of the anatomy is necessary because an isolated right aortic arch can be associated with an encircling aortic arch anomaly and may subsequently have a functional repercussion, creating a digestive obstacle (oesophageal compression) and/or a respiratory obstacle (tracheal compression).
Furthermore, indications for surgery in this type of abnormalities are not well-established.
Read more
The diagnosis of a vascular artery anomaly is currently mostly made prenatally, with increasing diagnostic accuracy. Indeed, the application of the "3VT view" (e.g. three vessels and tracheae view) in routine prenatal sonographic screening for CHD has contributed to a better identification of such anomalies.
Prenatal diagnosis of an isolated right aortic arch involves the identification of the following aspects: the existence of a left ductus arteriosus may relate to an increased risk of an encircling aortic arch anomaly at birth; the analysis of the different vessels of the aortic arch, which can be difficult because of the fetal circulation and the maternal-fetal conditions of the examination; and the absence of a thymus, which suggests the existence of a genetic anomaly, such as DiGeorge syndrome.
After birth, the evaluation of the functional repercussion of the anomaly remains complex. The incidence of secondary symptoms to encircling abnormalities is estimated at 25%, but varies according to the anomaly: it is very frequent in case of a double aortic arch, variable in case of a right aortic arch with left ductus arteriosus (from 9% to 47% in the literature), absent in case of right aortic arch with right ductus arteriosus. Postnatal echocardiography can only assess the existence of a right aortic arch and check ductus arteriosus closure. The complete anatomical diagnosis of a vascular artery anomaly can only be made by slice cardiac imaging (CT scan or MRI), but in practice these examinations are not routinely performed in the absence of neonatal symptoms.
The aim of this study is to evaluate the accuracy of prenatally diagnosed isolated right aortic arch in terms of anatomy and functional prognosis.
The secondary aims are :
- to specify the association of an isolated right aortic arch with a genetic anomaly,
- to define the role of CT scan in children prenatally diagnosed with right aortic arch, in terms of diagnosis, prognosis and follow-up,
- to evaluate the incidence of respiratory and digestive complications in the first year of life,
- to evaluate the indications for surgical management during the first year of life.
Read the detailed description
Retrospective (from 2010 to 2019), multicentre, observational study carried out in the French national M3C network (complex CHD expert centers).
Patients with a prenatal diagnosis of isolated right aortic arch will be included. Patients with a right aortic arch associated with any CHD will be excluded, as well as patients whose parents refuse the use of medical data of their child.
The following data will be collected:
Clinical data:
- Functional signs of tracheal or esophageal compression in the first year of life.
- Association with a genetic syndrome.
Echocardiographic data:
- Prenatal: anatomical description of the aorta and supra-aortic trunks. Position of the ductus arteriosus, presence of a thymus.
- Postnatal: confirmation of the right aortic arch, absence of conotruncal CHD, closure of the ductus arteriosus.
If performing a chest CT scan in the first year of life:
- Reason: systematic or on symptoms,
- Age of realization,
- Anatomical analysis of the aortic arches,
- Concordance with antenatal diagnosis,
- Evaluation of the degree of tracheal compression,
- Screening for a vascular complication.
If performing an ante- or post-natal genetic sampling:
- Type of sampling if antenatal: amniocentesis or trophoblast biopsy,
- Type of analysis: karyotype, FISH, CGH array,
- Molecular diagnosis.
If performing a surgery during the first year of life:
- Indication: prophylactic or symptomatic,
- Type of intervention,
- Age at the intervention
- Conditions
- Isolated Right Aortic Arch
- Keywords
- right aortic arch, congenital heart disease, pediatrics, cardiology, prenatal diagnosis
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the antenatal description of isolated right aortic arch and the postnatal description and functional prognosis
Correlation between the antenatal description of isolated right aortic arch and the postnatal description and functional prognosis
Measured: 1 day
Secondary outcomes (4)
Rate of genetic anomaly with an isolated right aortic arch
Incidence of genetic anomaly with an isolated right aortic arch by specifying :
- diagnosed retained
- type of sampling : amniocentesis, trophoblast biopsy, blood test
- type of analysis: karyotype, FISH, CGH array
Measured: 1 day
Rate of realization of chest CT angiography before the first year of life with an isolated right aortic arch
If performing a chest CT scan the first year of life:
- Reason: systematic or on symptoms
- Age of realization
- Anatomical analysis of the aortic arches
- Concordance with antenatal diagnosis
- Evaluation of the degree of tracheal compression
Measured: 1 day
Rate of surgical repair during the first year of life after prenatal diagnosis of an isolated right aortic arch.
If performing a surgery the first year of life:
- Indication: prophylactic or symptomatic
- Type of intervention
- Age at the intervention
Measured: 1 day
Rate of respiratory and digestive complications in the first year of life.
Functional signs of tracheal or esophageal compression in the first year of life.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Apr 2019
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
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 Isolated Right Aortic ArchStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Congeital heart disease explorations unit - UE3C Lowendal - Paris, University Hospital, Rouen, Nantes University Hospital, University Hospital, Grenoble, University Hospital, Bordeaux, Clinique La louvère - Lille - France, University Hospital, Tours, University Hospital, Caen, University Hospital, Toulouse, Hospices Civils de Lyon, University Hospital, Marseille, Amiens University Hospital, Martinique University Hospital, Centre Hospitalier Universitaire Dijon, Private cardiology practice, Massy, Private cardiology practice, Marseille, Private cardiology practice, Pontoise, Private cardiology practice, Strasbourg, Private cardiology practice, Brest, Private cardiology practice, Rennes
- Responsible party
- Sponsor
- Investigators
- Sophie GUILLAUMONT, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029064
- Sponsor's protocol ID
- RECHMPL19_0146
- Acronym
- ARCADE
- Status last verified
- Mar 2019
- First submitted
- 25 Apr 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Guillaumont S, Vincenti M, Thomas F, Huguet H, Picot MC, Abassi H, Huby AC, Laux D, Thomas-Chabaneix J, Cohen L, Gavotto A, Amedro P; ARCADE study group. Implications of right aortic arch prenatal diagnosis: the multicentric nationwide ARCADE cohort. Arch Dis Child Fetal Neonatal Ed. 2025 Feb 21;110(2):138-144. doi: 10.1136/archdischild-2024-327242.
PubMed 38964845
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Prenatally Diagnosed Isolated Right Aortic Arch: the ARCADE Study
- ClinicalTrials.gov ID
- NCT04029064
- Acronym / sponsor ID
- ARCADE / RECHMPL19_0146
- Conditions
- Isolated Right Aortic Arch
- Keywords
- right aortic arch, congenital heart disease, pediatrics, cardiology, prenatal diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Congeital heart disease explorations unit - UE3C Lowendal - Paris, University Hospital, Rouen, Nantes University Hospital, University Hospital, Grenoble, University Hospital, Bordeaux, Clinique La louvère - Lille - France, University Hospital, Tours, University Hospital, Caen, University Hospital, Toulouse, Hospices Civils de Lyon, University Hospital, Marseille, Amiens University Hospital, Martinique University Hospital, Centre Hospitalier Universitaire Dijon, Private cardiology practice, Massy, Private cardiology practice, Marseille, Private cardiology practice, Pontoise, Private cardiology practice, Strasbourg, Private cardiology practice, Brest, Private cardiology practice, Rennes
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 23 Jul 2019 (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.
The existence of a right aortic arch integrates nosologically into the group of aortic vascular arch anomalies. In the majority of cases, a right aortic arch is associated with cono-truncal congenital heart diseases (CHD), such as tetralogy of Fallot, pulmonary atresia with ventricular septal defect, and truncus arteriosus. Sometimes, a right aortic arch can be isolated, with an incidence of 0.05% to 0.1 %. Therefore, an assessment of the anatomy is necessary because an isolated right aortic arch can be associated with an encircling aortic arch anomaly and may subsequently have a functional repercussion, creating a digestive obstacle (oesophageal compression) and/or a respiratory obstacle (tracheal compression).
Furthermore, indications for surgery in this type of abnormalities are not well-established.
The diagnosis of a vascular artery anomaly is currently mostly made prenatally, with increasing diagnostic accuracy. Indeed, the application of the "3VT view" (e.g. three vessels and tracheae view) in routine prenatal sonographic screening for CHD has contributed to a better identification of such anomalies.
Prenatal diagnosis of an isolated right aortic arch involves the identification of the following aspects: the existence of a left ductus arteriosus may relate to an increased risk of an encircling aortic arch anomaly at birth; the analysis of the different vessels of the aortic arch, which can be difficult because of the fetal circulation and the maternal-fetal conditions of the examination; and the absence of a thymus, which suggests the existence of a genetic anomaly, such as DiGeorge syndrome.
After birth, the evaluation of the functional repercussion of the anomaly remains complex. The incidence of secondary symptoms to encircling abnormalities is estimated at 25%, but varies according to the anomaly: it is very frequent in case of a double aortic arch, variable in case of a right aortic arch with left ductus arteriosus (from 9% to 47% in the literature), absent in case of right aortic arch with right ductus arteriosus. Postnatal echocardiography can only assess the existence of a right aortic arch and check ductus arteriosus closure. The complete anatomical diagnosis of a vascular artery anomaly can only be made by slice cardiac imaging (CT scan or MRI), but in practice these examinations are not routinely performed in the absence of neonatal symptoms.
The aim of this study is to evaluate the accuracy of prenatally diagnosed isolated right aortic arch in terms of anatomy and functional prognosis.
The secondary aims are :
- to specify the association of an isolated right aortic arch with a genetic anomaly,
- to define the role of CT scan in children prenatally diagnosed with right aortic arch, in terms of diagnosis, prognosis and follow-up,
- to evaluate the incidence of respiratory and digestive complications in the first year of life,
- to evaluate the indications for surgical management during the first year of life.
Detailed description
Retrospective (from 2010 to 2019), multicentre, observational study carried out in the French national M3C network (complex CHD expert centers).
Patients with a prenatal diagnosis of isolated right aortic arch will be included. Patients with a right aortic arch associated with any CHD will be excluded, as well as patients whose parents refuse the use of medical data of their child.
The following data will be collected:
Clinical data:
- Functional signs of tracheal or esophageal compression in the first year of life.
- Association with a genetic syndrome.
Echocardiographic data:
- Prenatal: anatomical description of the aorta and supra-aortic trunks. Position of the ductus arteriosus, presence of a thymus.
- Postnatal: confirmation of the right aortic arch, absence of conotruncal CHD, closure of the ductus arteriosus.
If performing a chest CT scan in the first year of life:
- Reason: systematic or on symptoms,
- Age of realization,
- Anatomical analysis of the aortic arches,
- Concordance with antenatal diagnosis,
- Evaluation of the degree of tracheal compression,
- Screening for a vascular complication.
If performing an ante- or post-natal genetic sampling:
- Type of sampling if antenatal: amniocentesis or trophoblast biopsy,
- Type of analysis: karyotype, FISH, CGH array,
- Molecular diagnosis.
If performing a surgery during the first year of life:
- Indication: prophylactic or symptomatic,
- Type of intervention,
- Age at the intervention
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with antenatal diagnosis of isolated right aortic arch
Key inclusion criteria (1 listed)
- Prenatal diagnosis of an isolated right aortic arch
Key exclusion criteria (3 listed)
- Association with any congenital heart disease according to the ACC-CHD (Orphanet) classification
- Postnatal diagnosis of an isolated right aortic arch
- Refusal of parents to use medical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between the antenatal description of isolated right aortic arch and the postnatal description and functional prognosis
Time frame: 1 day
Correlation between the antenatal description of isolated right aortic arch and the postnatal description and functional prognosis
4 secondary outcomes
Rate of genetic anomaly with an isolated right aortic arch
Time frame: 1 day
Rate of realization of chest CT angiography before the first year of life with an isolated right aortic arch
Time frame: 1 day
Rate of surgical repair during the first year of life after prenatal diagnosis of an isolated right aortic arch.
Time frame: 1 day
Rate of respiratory and digestive complications in the first year of life.
Time frame: 1 day
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 10 Mar 2020.
- Derived from this study: PubMed 38964845Guillaumont S, Vincenti M, Thomas F, Huguet H, Picot MC, Abassi H, Huby AC, Laux D, Thomas-Chabaneix J, Cohen L, Gavotto A, Amedro P; ARCADE study group. Implications of right aortic arch prenatal diagnosis: the multicentric nationwide ARCADE cohort. Arch Dis Child Fetal Neonatal Ed. 2025 Feb 21;110(2):138-144. doi: 10.1136/archdischild-2024-327242.
- Individual participant dataSharing planned: Undecided. NC
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.
Sophie GUILLAUMONT, MD principal investigator
University Hospital, Montpellier
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 Isolated Right Aortic Arch, run by University Hospital, Montpellier at 1 site in France.
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 3 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 10 Mar 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 France. 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?
Correlation between the antenatal description of isolated right aortic arch and the postnatal description and functional prognosis (time frame: 1 day). 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 NCT04029064, 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 10 Mar 2020.