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Asynchrony in Operated Tetralogy of Fallot (FALLOT-XI)

Primary Purpose

Tetralogy of Fallot

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrophysiological exploration of the right ventricle
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tetralogy of Fallot focused on measuring FALLOT disease, CARTO, 3Dimension Echocardiography, mecanichal and electrical activation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Fallot group

Control group

Arm Description

Patient with Fallot Tetralogy operated

Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2022
Last Updated
August 2, 2022
Sponsor
University Hospital, Bordeaux
Collaborators
Reference Centre for Rare Diseases Malformations Congenital Heart Complexes (CRMR M3C-Bordeaux)
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1. Study Identification

Unique Protocol Identification Number
NCT05485545
Brief Title
Asynchrony in Operated Tetralogy of Fallot
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Reference Centre for Rare Diseases Malformations Congenital Heart Complexes (CRMR M3C-Bordeaux)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetralogy of Fallot
Keywords
FALLOT disease, CARTO, 3Dimension Echocardiography, mecanichal and electrical activation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fallot group
Arm Type
Other
Arm Description
Patient with Fallot Tetralogy operated
Arm Title
Control group
Arm Type
Other
Arm Description
Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia
Intervention Type
Other
Intervention Name(s)
Electrophysiological exploration of the right ventricle
Intervention Description
CARTO electrophysiological mapping system 3D echocardiography High Resolution MRI
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Area strain VD 3D global in %
Description
Global 3D VD longitudinal strain in %, Global 3D VD circumferential strain in %, Mean deformation pattern, Mean RV right ventricle shape, RV Average Curvature Index.
Time Frame
Day 0
Title
Strain longitudinal VD 3D at the 8 segments in %
Time Frame
Day 0
Title
Strain circumferential VD 3D at the 8 segments in %
Time Frame
Day 0
Title
Comparison of 3D VD volume data between different populations
Description
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.
Time Frame
Day 0
Title
Inter-evaluator variability of 3D deformation parameters
Description
Area strain 3D in %, Longitudinal strain in %, Circumferential strain in %, Global 3D at right ventricle level.
Time Frame
Day 0
Title
Intra-evaluator variability of 3D deformation parameters
Description
Area strain 3D in %, Longitudinal strain in %, Circumferential strain in %, Global 3D at right ventricle level.
Time Frame
Day 0
Title
MR Analysis
Description
Right and Left Ventricular MRI Volumetry; Pulmonary flow by MRI. T1 spontaneous (ms) and extracellular volume fraction (%) by MRI MRI scar area
Time Frame
Day 0
Title
Comparison of electrical activation maps based on anatomical data
Description
Comparison of electrical activation maps based on anatomical data, including diffuse fibrosis and scars in Fallot subjects
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier IRART, MD
Phone
(0)5 57 65 64 65
Ext
+33
Email
xavier.iriart@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile JORE
Phone
(0)5 57 65 66 66
Ext
+33
Email
cecile.jore@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier IRART, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier IRIART, MD
Phone
(0)5 57 65 64 65
Ext
+33
Email
xavier.iriart@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Emilie TESTET, MD
First Name & Middle Initial & Last Name & Degree
Frédéric SACHER, MD,PhD
First Name & Middle Initial & Last Name & Degree
Hubert COCHET, MD,PhD

12. IPD Sharing Statement

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Asynchrony in Operated Tetralogy of Fallot

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