Congenital Heart DiseaseNCT02408848
The Value of Three Dimensional Echocardiography in Congenital Cardiac Surgery
An observational study of Congenital Heart Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
There are few studies evaluating the value of 3D echocardiography in children undergoing congenital cardiac surgery. The aim of this observational study is to describe common and uncommon congenital malformations with the help of 3D echo and compare the findings and the measurements with those obtained with… Read more about this study
- Who is it for?
- Ages 5 hours to 18 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Observational
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2015to Sep 2016
- 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 5 hours to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children undergoing congenital cardiac surgery with or without cardiopulmonary bypass
Who may be able to join
- All children requiring general anesthesia for congenital heart surgery and in whom informed parental consent has been obtained
Who cannot join
- Children with congenital heart disease who do not require heart surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Dimensional Echocardiography in Congenital Cardiac Surgery
There are few studies evaluating the value of 3D echocardiography in children undergoing congenital cardiac surgery. The aim of this observational study is to describe common and uncommon congenital malformations with the help of 3D echo and compare the findings and the measurements with those obtained with conventional 2D echo.
- Conditions
- Congenital Heart Disease
- Being tested
- Observational
- 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.
ObservationalOther
This is an observational study. There is no intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
correlate three dimensional measurements with two dimensional measurements
correlation of two dimensional transthoracic echo with three dimensional transthoracic echo
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: No three dimensional transthoracic echo available currently
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Momeni, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408848
- Sponsor's protocol ID
- 2015/06JAN/006
- Status last verified
- Apr 2019
- First submitted
- 18 Mar 2015
- Last updated
- 8 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Echocardiography in Congenital Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02408848
- Acronym / sponsor ID
- 2015/06JAN/006
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No three dimensional transthoracic echo available currently
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Apr 2015 (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.
There are few studies evaluating the value of 3D echocardiography in children undergoing congenital cardiac surgery. The aim of this observational study is to describe common and uncommon congenital malformations with the help of 3D echo and compare the findings and the measurements with those obtained with conventional 2D echo.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 hours to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing congenital cardiac surgery with or without cardiopulmonary bypass
Key inclusion criteria (1 listed)
- All children requiring general anesthesia for congenital heart surgery and in whom informed parental consent has been obtained
Key exclusion criteria (1 listed)
- Children with congenital heart disease who do not require heart surgery
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 |
|---|---|---|
| ObservationalThis is an observational study. There is no intervention. | Other | – |
Primary outcome
correlate three dimensional measurements with two dimensional measurements
Time frame: 1 month
correlation of two dimensional transthoracic echo with three dimensional transthoracic echo
Results and safety
The study was stopped early (reason given: No three dimensional transthoracic echo available currently). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cliniques universitaires Saint-Luc- Université Catholique de Louvain 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: stopped early, as of the sponsor's last update on 8 Apr 2019. 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 was stopped early (reason given: No three dimensional transthoracic echo available currently). Results are not available in the source record.
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?
correlate three dimensional measurements with two dimensional measurements (time frame: 1 month). 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 8 Apr 2019.