Asynchrony in Operated Tetralogy of Fallot

NCT ID: NCT05485545

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-09-01

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.

Conditions

Tetralogy of Fallot

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Fallot group

Patient with Fallot Tetralogy operated

Group Type: OTHER

Electrophysiological exploration of the right ventricle

Intervention Type: OTHER

• CARTO electrophysiological mapping system
• 3D echocardiography
• High Resolution MRI

Control group

Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia

Group Type: OTHER

Electrophysiological exploration of the right ventricle

Intervention Type: OTHER

• CARTO electrophysiological mapping system
• 3D echocardiography
• High Resolution MRI

Interventions

Electrophysiological exploration of the right ventricle

• CARTO electrophysiological mapping system
• 3D echocardiography
• High Resolution MRI

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reference Centre for Rare Diseases Malformations Congenital Heart Complexes (CRMR M3C-Bordeaux)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier IRART, MD

Role: STUDY_DIRECTOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Central Contacts

Xavier IRART, MD

Role: CONTACT

xavier.iriart@chu-bordeaux.fr

(0)5 57 65 64 65 ext. +33

Cécile JORE

Role: CONTACT

cecile.jore@chu-bordeaux.fr

(0)5 57 65 66 66 ext. +33

Facility Contacts

Xavier IRIART, MD

Role: primary

xavier.iriart@chu-bordeaux.fr

(0)5 57 65 64 65 ext. +33

Other Identifiers

2021-A00770-41

Identifier Type: OTHER

Identifier Source: secondary_id

CHUBX 2019/39

Identifier Type: -

Identifier Source: org_study_id