The Value of Three Dimensional Echocardiography in Congenital Cardiac Surgery

NCT02408848 | Terminated

• 1 other identifier: 2015/06JAN/006
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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 conventional 2D echo.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• correlate three dimensional measurements with two dimensional measurements

  correlation of two dimensional transthoracic echo with three dimensional transthoracic echo

  1 month

Interventions

Observational OTHER

This is an observational study. There is no intervention.

Eligibility Criteria

• Age: 5 Hours - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing congenital cardiac surgery with or without cardiopulmonary bypass

You may qualify if:

• All children requiring general anesthesia for congenital heart surgery and in whom informed parental consent has been obtained

You may not qualify if:

• Children with congenital heart disease who do not require heart surgery

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chef de Clinique associée

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: April 6, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

BE (1)