Clinical trial NCT05485545: Asynchrony in Operated Tetralogy of Fallot
Official title: Exploring Asynchronism in Operated Fallot Tetralogy : A Comparative Study of Electrical and Mechanical Activation of the Right Ventricle by Three-Dimensional Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tetralogy of Fallot
Keywords: FALLOT disease
CARTO
3Dimension Echocardiography
mecanichal and electrical activation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Reference Centre for Rare Diseases Malformations Congenital Heart Complexes (CRMR M3C-Bordeaux)
First posted: 2022-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria in the Fallot group

* 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.

Exclusion Criteria:

Exclusion Criteria in the Fallot group

* 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.

Exclusion Criteria in the Control group

* 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.

Primary outcomes:
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.
timeFrame: Day 0
Secondary outcomes:
measure: Area strain VD 3D global in %
timeFrame: Day 0
measure: Strain longitudinal VD 3D at the 8 segments in %
timeFrame: Day 0
measure: Strain circumferential VD 3D at the 8 segments in %
timeFrame: Day 0
measure: Comparison of 3D VD volume data between different populations
timeFrame: Day 0
measure: Inter-evaluator variability of 3D deformation parameters
timeFrame: Day 0
measure: Intra-evaluator variability of 3D deformation parameters
timeFrame: Day 0
measure: MR Analysis
timeFrame: Day 0
measure: Comparison of electrical activation maps based on anatomical data
timeFrame: Day 0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Xavier IRART, MD
role: STUDY_DIRECTOR
References: