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Imaging by 4 DFlow in Patients With Tetralogy of Fallot (4DFlowFallot)

Primary Purpose

Congenital Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
magnetic resonance imaging
Sponsored by
Centre Chirurgical Marie Lannelongue
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Heart Disease focused on measuring Congenital heart disease, Tetralogy of Fallot, Imaging by 4D Flow,, Magnetic resonance imaging, Prevention of ventricular dysfunction

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • - children from the age of 10 and above without any upper age limit;
  • giving their informed consent for the study;
  • with a corrected tetralogy of Fallot;
  • sent for a follow-up imaging examination with endomyocardial fibrosis screening;

Exclusion Criteria:

  • - pregnant woman;
  • children <10 years old;
  • All contraindications inherent to MRI: (claustrophobia, ferromagnetic intracorporeal foreign bodies)
  • Contraindication to contrast media injection (Gadolinium)

Sites / Locations

  • Hôpital Marie LannelongueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

4D magnetic resonance imaging

2D magnetic resonance imaging

Arm Description

MRI, 4D imaging, acquisition and analysis of 4D cardiac MRI images-A single, faster acquisition (8 to 15 minutes).

MRI, 2D imaging, acquisition and analysis of 2D cardiac MRI

Outcomes

Primary Outcome Measures

Comparison of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI.
Assessment of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI : regurgitation volume (ml) and regurgitation fraction (%).

Secondary Outcome Measures

Compare the evaluation of right ventricle volumes using 2D MRI and 4D Flow MRI.
Assessment of the end-diastolic and end-systolic right ventricle volumes using 2D MRI and 4D Flow MRI (ml).

Full Information

First Posted
May 4, 2018
Last Updated
January 21, 2020
Sponsor
Centre Chirurgical Marie Lannelongue
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1. Study Identification

Unique Protocol Identification Number
NCT03542968
Brief Title
Imaging by 4 DFlow in Patients With Tetralogy of Fallot
Acronym
4DFlowFallot
Official Title
Imaging by 4 DFlow in Patients With Tetralogy of Fallot
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
October 11, 2019 (Actual)
Study Completion Date
April 11, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Chirurgical Marie Lannelongue

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Conventionnal cadiac magnetic resonance (CMR) is the reference to assess changes in right heart flow and pulmonary artery hemodynamics in patients with repaired Tetralogy of Fallot. 4D Flow CMR Imaging is a new imaging modality able to assess all of these parameters faster (8 min vs 30 min) and more comfortably. The aim of this study is to compare conventionnal CMR and 4D Flow CMR for the assessment of these parameters (ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway).
Detailed Description
Congenital heart disease, or corrected heart disease requires regular, specialized follow-up throughout the life of these patients. Among the recommended examinations, cardiac MRI is the reference for functionnal ventricles assessment (volume/systolic function), particularly for the right ventricle. Among these pathologies, the tetralogy of Fallot is indicative of the increasing importance of cardiac MRI. In this disease, strong parameters has been identifies for the follow to prevent right ventricle dysfunction and ventricular arrhythmias. They rely on right ventricle volumes and on the pulmonary artery regurgitation, both using cardiac MRI. However, this imaging modality imposes constraints such as a long acquisition times (30 to 40 min) or the need to hold apneas, which may render the procedure uncomfortable, even more in the case of very young patients. The idea of exploring a new imaging modality is therefore based on the willingness to offer a faster and more comfortable examination. 4D Flow MRI could enable conventionnal parameters, detection of both normal and abnormal right heart flow patterns, and may allow comprehensive analysis of post-surgically altered geometries and hemodynamics. 4D Flow MRI cardiac imaging is : A single and faster acquisition (8 to 15 minutes) that cardiac MRI. A free breathing acquisition Imaging modality. A quite-isotropic assessment. A technically simple exam (a single sequence requiring low competence). And offers unlimited post processing. The investigators hypothesize that 4D MRI is non-inferior to 2D MRI in patients with corrected tetralogy of Fallot, for the evaluation of conventional cardiac evaluation parameters: ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway. The investigators hypothesize that 4D MRI is superior to 2D MRI in patients with corrected tetralogy of Fallot, as ti allows to identifying new predictors of ventricular dysfunction such as intravenous extracardiac turbulent / laminar flow character, preferential orientation, flow distribution and trans-tricuspid diastolic flow.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Congenital heart disease, Tetralogy of Fallot, Imaging by 4D Flow,, Magnetic resonance imaging, Prevention of ventricular dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4D magnetic resonance imaging
Arm Type
Experimental
Arm Description
MRI, 4D imaging, acquisition and analysis of 4D cardiac MRI images-A single, faster acquisition (8 to 15 minutes).
Arm Title
2D magnetic resonance imaging
Arm Type
Sham Comparator
Arm Description
MRI, 2D imaging, acquisition and analysis of 2D cardiac MRI
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Description
Acquisition 4D Flow magnetic resonance Imaging-8 minutes
Primary Outcome Measure Information:
Title
Comparison of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI.
Description
Assessment of the pulmonary artery regurgitation using 2D MRI and 4D Flow MRI : regurgitation volume (ml) and regurgitation fraction (%).
Time Frame
20 min
Secondary Outcome Measure Information:
Title
Compare the evaluation of right ventricle volumes using 2D MRI and 4D Flow MRI.
Description
Assessment of the end-diastolic and end-systolic right ventricle volumes using 2D MRI and 4D Flow MRI (ml).
Time Frame
20 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - children from the age of 10 and above without any upper age limit; giving their informed consent for the study; with a corrected tetralogy of Fallot; sent for a follow-up imaging examination with endomyocardial fibrosis screening; Exclusion Criteria: - pregnant woman; children <10 years old; All contraindications inherent to MRI: (claustrophobia, ferromagnetic intracorporeal foreign bodies) Contraindication to contrast media injection (Gadolinium)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olaf Mercier, Professor
Phone
+33140948695
Email
o.mercier@hml.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Antoine ISORNI, Doctor
Organizational Affiliation
Hôpital Marie Lannelongue
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Marie Lannelongue
City
Le Plessis-Robinson
ZIP/Postal Code
92350
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc antoine ISORNI
Phone
+33140948554
Email
ma-isorni@hml.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Imaging by 4 DFlow in Patients With Tetralogy of Fallot

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