Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping. (NCT05296954) | Clinical Trial Compass
RecruitingNot Applicable
Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping.
France20 participantsStarted 2022-02-04
Plain-language summary
The aim of the present work is to analyze the capacity of high resolution mapping systems to determine the precise location of the AV node and peri-nodal slow-conducting pathways, using standard recording parameters, but also off-line additional filter changes and additional techniques (conduction velocities, isochrones and dV/dt). The investigative team plan a prospective monocentric study.
Detailed high resolution mapping of the Koch triangle and neighboring areas will be collected through the RHYTHMIA HDx 3D electro-anatomical mapping system and the multipolar ORION catheter. This sample will consist of 2 groups of patients: the first will include patients referred for AVNRT ablation and the second will include control patients (without AVNRT), referred for another indication requiring similar mapping system. If visualized, position of the slow pathway and AV node will be compared with the ablation areas, which will be set conventionally under fluoroscopy.
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:
Group 1: Patients without heart disease presenting with reciprocal tachycardia by intra-nodal reentry.
Group 2: Control subjects, without nodal tachycardia, without heart disease, and admitted for ablation of atrial fibrillation or ventricular extrasystoles on a healthy heart and with a 3D system.
Exclusion Criteria:
* Presence of underlying structural heart disease or history of atrial ablation or atrial tachycardia
* Minor or protected patient
* Patient under guardianship, curatorship or safeguard of justice
Questions worth asking your doctor
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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?
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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.