Magnetic Resonance ImagingCARDIOFLUXNCT02980614
4D Velocity Mapping of the Heart in rTOF Patients
A study testing 4D flow imaging in people with Magnetic Resonance Imaging and Tetralogy of Fallot, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Magnetic Resonance Imaging, Tetralogy of Fallot
- What is being tested?
- 4D flow imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2017to 3 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Tetralogy of Fallot patients
- referred for clinical MRI examination
- ≥ 15 years
Who cannot join
- Anyone with a classic contraindication to MRI
- Severe obesity
- Gadolinium chelate allergy
- < 15 years
- counter-indication to MRI examination
- vulnerable person
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume
MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.
Read the detailed description
MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence. The objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA flow +RightPA flow ? ).
- Conditions
- Magnetic Resonance Imaging, Tetralogy of Fallot
- Being tested
- 4D flow imaging
- Keywords
- phase-contrast MRI, blood flow, velocity mapping, Quantitative MRI, Cardiac imaging, Tetralogy of Fallot
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4D flow imagingDevice
To compare the quantification of pulmonary valve leakage by standard 2D flow MRI and 4D flow MRI by measuring the regurgitation fraction (ratio of retrograde blood flow to anterograde flow) in the pulmonary artery
| Study group | Role | What they receive |
|---|---|---|
| Participants to 4D flow imaging | Experimental | In addition to the standard clinical MR protocol, 2 added sequences:
4D MR sequence in cine mode 4D velocity mapping sequence Receives: Device: 4D flow imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regurgitant fraction comparison
The primary objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured with 4D MR-flow and standard 2D MR-flow.
Measured: Day 0
Secondary outcomes (2)
Right ventricular volume
The secondary objective is to compare the right ventricular volumes measured using the 4D prototype and the standard steady-state free precession sequences.
Measured: Day 0
Pulmonary arteries flows
The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery (PA) tree (PA flow =LeftPA flow +RightPA flow ? ).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start27 Mar 2017
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cedric Renard, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980614
- Sponsor's protocol ID
- PI2016_843_0026
- Acronym
- CARDIOFLUX
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2016
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume
- ClinicalTrials.gov ID
- NCT02980614
- Acronym / sponsor ID
- CARDIOFLUX / PI2016_843_0026
- Conditions
- Magnetic Resonance Imaging, Tetralogy of Fallot
- Keywords
- phase-contrast MRI, blood flow, velocity mapping, Quantitative MRI, Cardiac imaging, Tetralogy of Fallot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.
Detailed description
MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence. The objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured using 4D MR-flow and standard 2D MR-flow in repaired Tetralogy of Fallot (rTOF) patients. The consistency of the 4D flow quantization will be assessed assuming mass conservation in the pulmonary artery tree (PA flow =LeftPA flow +RightPA flow ? ).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants to 4D flow imaging | Experimental | Device: 4D flow imagingIn addition to the standard clinical MR protocol, 2 added sequences: 4D MR sequence in cine mode 4D velocity mapping sequence |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Tetralogy of Fallot patients
- referred for clinical MRI examination
- ≥ 15 years
Key exclusion criteria (6 listed)
- Anyone with a classic contraindication to MRI
- Severe obesity
- Gadolinium chelate allergy
- < 15 years
- counter-indication to MRI examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4D flow imagingTo compare the quantification of pulmonary valve leakage by standard 2D flow MRI and 4D flow MRI by measuring the regurgitation fraction (ratio of retrograde blood flow to anterograde flow) in the pulmonary artery | Device | Participants to 4D flow imaging |
Primary outcome
Regurgitant fraction comparison
Time frame: Day 0
The primary objective of the project is to compare the regurgitant fraction in the pulmonary artery (PA) measured with 4D MR-flow and standard 2D MR-flow.
2 secondary outcomes
Right ventricular volume
Time frame: Day 0
Pulmonary arteries flows
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cedric Renard, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4D flow imaging in people with Magnetic Resonance Imaging and Tetralogy of Fallot, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regurgitant fraction comparison (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.