WithdrawnNot Applicable

Asynchrony in Operated Tetralogy of Fallot

Stopped: expired authorizations, the study will be revised

France0Started 2022-09-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05485545

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Tetralogy of Fallot trials