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

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).

Study Overview

• Status: Unknown
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Procedure: magnetic resonance imaging

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Plessis-Robinson, France, 92350
    • Recruiting
    • Hôpital Marie Lannelongue
    • Contact: Marc antoine ISORNI; Phone Number: +33140948554; Email: ma-isorni@hml.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4D magnetic resonance imaging; MRI, 4D imaging, acquisition and analysis of 4D cardiac MRI images-A single, faster acquisition (8 to 15 minutes).	Procedure: magnetic resonance imaging; Acquisition 4D Flow magnetic resonance Imaging-8 minutes
Sham Comparator: 2D magnetic resonance imaging; MRI, 2D imaging, acquisition and analysis of 2D cardiac MRI	Procedure: magnetic resonance imaging; Acquisition 4D Flow magnetic resonance Imaging-8 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	20 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	20 min

Collaborators and Investigators

• Sponsor: Centre Chirurgical Marie Lannelongue
• Investigators: Principal Investigator: Marc Antoine ISORNI, Doctor, Hôpital Marie Lannelongue

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Actual): October 11, 2019
• Study Completion (Anticipated): April 11, 2020

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Congenital heart disease; Tetralogy of Fallot; Imaging by 4D Flow,; Prevention of ventricular dysfunction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Tetralogy of Fallot; Heart Defects, Congenital
• Other Study ID Numbers: 2017-A01482-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No