Tetralogy of FallotFALLOT-XINCT05485545
Asynchrony in Operated Tetralogy of Fallot
A study testing Electrophysiological exploration of the right ventricle in people with Tetralogy of Fallot, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The objective of this work is to estimate the correlation between the electrical activation of the VD measured by the CARTO electrophysiological mapping system and the mechanical activation of the VD measured by 3D echocardiography and 3D speckle-tracking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetralogy of Fallot
- What is being tested?
- Electrophysiological exploration of the right ventricle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 1 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged 18,
- Patient with Fallot Tetralogy operated.
- nclusion Criteria in the Control group
- Male or female patient aged 18,
- Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia,
- Patient with a significant lack of heart disease.
Who cannot join
- Patient with associated left heart disease,
- Patient with an acoustic window that does not allow for proper echocardiography,
- Patient with contraindication to MRI,
- Woman of childbearing age without effective contraception (HAS criteria) or Pregnant (ßHCG > 20 IU/l) or nursing woman.
- Patient with an acoustic window that does not allow proper echocardiography,
- Patient with MRI contraindication,
- Woman of childbearing age without effective contraception (HAS criteria) or Pregnant (ßHCG > 20 IU/l) or nursing woman,
- Cardiac pathology detected during echocardiography.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Asynchronism in Operated Fallot Tetralogy : A Comparative Study of Electrical and Mechanical Activation of the Right Ventricle by Three-Dimensional Analysis
The objective of this work is to estimate the correlation between the electrical activation of the VD measured by the CARTO electrophysiological mapping system and the mechanical activation of the VD measured by 3D echocardiography and 3D speckle-tracking. Our hypothesis is that there is a strong correlation between electrical activation and mechanical activation in patients with an operated Fallot tetralogy.
Read the detailed description
Fallot tetralogy is the most common cyanogenic congenital heart disease. Thanks to advances in surgery, most patients survive to adulthood but develop a failure of the function of the right ventricle and then of the left ventricle resulting in progressive heart failure and death of patients. Despite corrective surgeries in adulthood, including pulmonary valve surgery, heart failure remains a major problem. One of the mechanisms of this heart failure is the right intraventtricular asynchronism associated with the postoperative right branch block, which will secondaryly become complicated from an interventricular asynchronism for left intraventtricular, partly explaining the overall progressive failure of cardiac function. To date, there is no model for combining a combined analysis of electrical and mechanical activation in the same patients. Understanding these mechanisms would allow us to better understand the pathophysiology of heart failure in this population and to propose targeted therapies to prevent this asynchronism by adapting surgical techniques, or treating this asynchronism with electrical therapy such as bivascular resynchronization.
Each patient in each group will perform, according to standard practice, an electrophysiological exploration with mapping of the heart using the CARTO system, a cardiac MRI and a 3-dimensional transthoracic echocardiography.
The follow-up of each patient takes place during a scheduled hospitalization as part of the care. Their participation in the study only lasts for the duration of the hospitalization.
- Conditions
- Tetralogy of Fallot
- Being tested
- Electrophysiological exploration of the right ventricle
- Keywords
- FALLOT disease, CARTO, 3Dimension Echocardiography, mecanichal and electrical activation
- 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.
Electrophysiological exploration of the right ventricleOther
- CARTO electrophysiological mapping system
- 3D echocardiography
- High Resolution MRI
| Study group | Role | What they receive |
|---|---|---|
| Fallot group | Other | Patient with Fallot Tetralogy operated Receives: Other: Electrophysiological exploration of the right ventricle |
| Control group | Other | Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia Receives: Other: Electrophysiological exploration of the right ventricle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of electrical and mechanical activation by computational morphometry with temporal recalling to define electromechanical activation maps in healthy subjects and patients with Fallot tetralogy operated.
Measured: Day 0
Secondary outcomes (8)
Area strain VD 3D global in %
Global 3D VD longitudinal strain in %, Global 3D VD circumferential strain in %, Mean deformation pattern, Mean RV right ventricle shape, RV Average Curvature Index.
Measured: Day 0
Strain longitudinal VD 3D at the 8 segments in %
Measured: Day 0
Strain circumferential VD 3D at the 8 segments in %
Measured: Day 0
Comparison of 3D VD volume data between different populations
3D VD Ejection Fraction and End-Diastolic and End-Systolic Volume 3D VD; 3D right ventricle volume data processed by Tomtec 4D RV Function 2.0.
Measured: Day 0
Inter-evaluator variability of 3D deformation parameters
Area strain 3D in %, Longitudinal strain in %, Circumferential strain in %, Global 3D at right ventricle level.
Measured: Day 0
Intra-evaluator variability of 3D deformation parameters
Area strain 3D in %, Longitudinal strain in %, Circumferential strain in %, Global 3D at right ventricle level.
Measured: Day 0
MR Analysis
- Right and Left Ventricular MRI Volumetry;
- Pulmonary flow by MRI.
- T1 spontaneous (ms) and extracellular volume fraction (%) by MRI
- MRI scar area
Measured: Day 0
Comparison of electrical activation maps based on anatomical data
Comparison of electrical activation maps based on anatomical data, including diffuse fibrosis and scars in Fallot subjects
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 posted3 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Why it stopped: expired authorizations, the study will be revised
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Reference Centre for Rare Diseases Malformations Congenital Heart Complexes (CRMR M3C-Bordeaux)
- Responsible party
- Sponsor
- Investigators
- Xavier IRART, MD, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485545
- Sponsor's protocol ID
- CHUBX 2019/39
- Other IDs
- 2021-A00770-41
- Acronym
- FALLOT-XI
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Asynchronism in Operated Fallot Tetralogy : A Comparative Study of Electrical and Mechanical Activation of the Right Ventricle by Three-Dimensional Analysis
- ClinicalTrials.gov ID
- NCT05485545
- Acronym / sponsor ID
- FALLOT-XI / CHUBX 2019/39
- Conditions
- Tetralogy of Fallot
- Keywords
- FALLOT disease, CARTO, 3Dimension Echocardiography, mecanichal and electrical activation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: expired authorizations, the study will be revised
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Reference Centre for Rare Diseases Malformations Congenital Heart Complexes (CRMR M3C-Bordeaux)
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 3 Aug 2022 (actual)
- 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.
The objective of this work is to estimate the correlation between the electrical activation of the VD measured by the CARTO electrophysiological mapping system and the mechanical activation of the VD measured by 3D echocardiography and 3D speckle-tracking. Our hypothesis is that there is a strong correlation between electrical activation and mechanical activation in patients with an operated Fallot tetralogy.
Detailed description
Fallot tetralogy is the most common cyanogenic congenital heart disease. Thanks to advances in surgery, most patients survive to adulthood but develop a failure of the function of the right ventricle and then of the left ventricle resulting in progressive heart failure and death of patients. Despite corrective surgeries in adulthood, including pulmonary valve surgery, heart failure remains a major problem. One of the mechanisms of this heart failure is the right intraventtricular asynchronism associated with the postoperative right branch block, which will secondaryly become complicated from an interventricular asynchronism for left intraventtricular, partly explaining the overall progressive failure of cardiac function. To date, there is no model for combining a combined analysis of electrical and mechanical activation in the same patients. Understanding these mechanisms would allow us to better understand the pathophysiology of heart failure in this population and to propose targeted therapies to prevent this asynchronism by adapting surgical techniques, or treating this asynchronism with electrical therapy such as bivascular resynchronization.
Each patient in each group will perform, according to standard practice, an electrophysiological exploration with mapping of the heart using the CARTO system, a cardiac MRI and a 3-dimensional transthoracic echocardiography.
The follow-up of each patient takes place during a scheduled hospitalization as part of the care. Their participation in the study only lasts for the duration of the hospitalization.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fallot group | Other | Other: Electrophysiological exploration of the right ventriclePatient with Fallot Tetralogy operated |
| Control group | Other | Other: Electrophysiological exploration of the right ventriclePatient benefiting from electrophysiological exploration for a healthy heart arrhythmia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patient aged 18,
- Patient with Fallot Tetralogy operated.
- nclusion Criteria in the Control group
- Male or female patient aged 18,
- Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia,
Key exclusion criteria (8 listed)
- Patient with associated left heart disease,
- Patient with an acoustic window that does not allow for proper echocardiography,
- Patient with contraindication to MRI,
- Woman of childbearing age without effective contraception (HAS criteria) or Pregnant (ßHCG > 20 IU/l) or nursing woman.
- Patient with an acoustic window that does not allow proper echocardiography,
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 |
|---|---|---|
| Electrophysiological exploration of the right ventricle* CARTO electrophysiological mapping system * 3D echocardiography * High Resolution MRI | Other | Control group, Fallot group |
Primary outcome
Comparison of electrical and mechanical activation by computational morphometry with temporal recalling to define electromechanical activation maps in healthy subjects and patients with Fallot tetralogy operated.
Time frame: Day 0
8 secondary outcomes
Area strain VD 3D global in %
Time frame: Day 0
Strain longitudinal VD 3D at the 8 segments in %
Time frame: Day 0
Strain circumferential VD 3D at the 8 segments in %
Time frame: Day 0
Comparison of 3D VD volume data between different populations
Time frame: Day 0
Inter-evaluator variability of 3D deformation parameters
Time frame: Day 0
Intra-evaluator variability of 3D deformation parameters
Time frame: Day 0
MR Analysis
Time frame: Day 0
Comparison of electrical activation maps based on anatomical data
Time frame: Day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Related trials for Tetralogy of Fallot
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
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.
Xavier IRART, MD study director
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiological exploration of the right ventricle in people with Tetralogy of Fallot, run by University Hospital, Bordeaux 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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 23 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 was withdrawn before enrolling participants, so there are no results.
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?
Comparison of electrical and mechanical activation by computational morphometry with temporal recalling to define electromechanical activation maps in healthy subjects and patients with Fallot tetralogy operated. (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 23 Jun 2026.