The Value of Three Dimensional Echocardiography in Congen... | NCT02408848

Studies
The Value of Three Dimensional Echocardiography in Congenital Cardiac Surgery

NCT02408848

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Terminated

Last Update Posted

Apr 8, 2019Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Observational

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No three dimensional transthoracic echo available currently

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Mar 18, 2015

First Submission Date that Met QC Criteria

Mar 31, 2015

First Posted Date

Apr 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2019

Last Update Posted Date

Apr 8, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mona Momeni, MD, PhD, Chef de Clinique associée, Cliniques universitaires Saint-Luc- Université Catholique de LouvainPrincipal Investigator

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	This is an observational study. There is no intervention.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlate three dimensional measurements with two dimensional measurements	correlation of two dimensional transthoracic echo with three dimensional transthoracic echo	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Hours

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children undergoing congenital cardiac surgery with or without cardiopulmonary bypass

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires Saint Luc		Brussels		1200	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided