- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408848
The Value of Three Dimensional Echocardiography in Congenital Cardiac Surgery
April 4, 2019 updated by: Mona Momeni, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
9
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussels, Belgium, 1200
- Cliniques Universitaires Saint Luc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 hours to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children undergoing congenital cardiac surgery with or without cardiopulmonary bypass
Description
Inclusion Criteria:
- All children requiring general anesthesia for congenital heart surgery and in whom informed parental consent has been obtained
Exclusion Criteria:
- Children with congenital heart disease who do not require heart surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
correlate three dimensional measurements with two dimensional measurements
Time Frame: 1 month
|
correlation of two dimensional transthoracic echo with three dimensional transthoracic echo
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
March 18, 2015
First Submitted That Met QC Criteria
March 31, 2015
First Posted (Estimate)
April 6, 2015
Study Record Updates
Last Update Posted (Actual)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 4, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/06JAN/006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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