Asynchrony in Operated Tetralogy of Fallot

Tetralogy of Fallot Clinical Trial

— FALLOT-XI  

Official title:

Exploring Asynchronism in Operated Fallot Tetralogy : A Comparative Study of Electrical and Mechanical Activation of the Right Ventricle by Three-Dimensional Analysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05485545
• Other study ID #: CHUBX 2019/39
• Secondary ID: 2021-A00770-41
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2022
• Source: University Hospital, Bordeaux
• Contact: Xavier IRART, MD
• Phone: (0)5 57 65 64 65
• Email: xavier.iriart[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Our hypothesis is that there is a strong correlation between electrical activation and mechanical activation in patients with an operated Fallot tetralogy.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tetralogy of Fallot

Intervention

Other:
• Electrophysiological exploration of the right ventricle
CARTO electrophysiological mapping system 3D echocardiography High Resolution MRI

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Reference Centre for Rare Diseases Malformations Congenital Heart Complexes (CRMR M3C-Bordeaux)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Day 0
Secondary	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.	Day 0
Secondary	Strain longitudinal VD 3D at the 8 segments in %		Day 0
Secondary	Strain circumferential VD 3D at the 8 segments in %		Day 0
Secondary	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.	Day 0
Secondary	Inter-evaluator variability of 3D deformation parameters	Area strain 3D in %, Longitudinal strain in %, Circumferential strain in %, Global 3D at right ventricle level.	Day 0
Secondary	Intra-evaluator variability of 3D deformation parameters	Area strain 3D in %, Longitudinal strain in %, Circumferential strain in %, Global 3D at right ventricle level.	Day 0
Secondary	MR Analysis	Right and Left Ventricular MRI Volumetry; Pulmonary flow by MRI.; T1 spontaneous (ms) and extracellular volume fraction (%) by MRI; MRI scar area	Day 0
Secondary	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	Day 0