NCT05485545

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 3, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 26, 2022

Last Update Submit

August 2, 2022

Conditions

Tetralogy of Fallot

Keywords

FALLOT diseaseCARTO3Dimension Echocardiographymecanichal and electrical activation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Area strain VD 3D global in %

    Day 0

  • Strain longitudinal VD 3D at the 8 segments in %

    Day 0

  • Strain circumferential VD 3D at the 8 segments in %

    Day 0

  • Comparison of 3D VD volume data between different populations

    Day 0

  • Inter-evaluator variability of 3D deformation parameters

    Day 0

  • +3 more secondary outcomes

Study Arms (2)

Fallot group

OTHER

Patient with Fallot Tetralogy operated

Other: Electrophysiological exploration of the right ventricle

Control group

OTHER

Patient benefiting from electrophysiological exploration for a healthy heart arrhythmia

Other: Electrophysiological exploration of the right ventricle

Interventions

Electrophysiological exploration of the right ventricleOTHER

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

Control groupFallot group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Xavier IRART, MD

    University Hospital, Bordeaux

    STUDY DIRECTOR

Central Study Contacts

Xavier IRART, MD

CONTACT

(0)5 57 65 64 65xavier.iriart@chu-bordeaux.fr

Cécile JORE

CONTACT

(0)5 57 65 66 66cecile.jore@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 3, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

August 3, 2022

Record last verified: 2022-07

Locations

FR(1)