Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping.

NCT ID: NCT05296954

Last Updated: 2024-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-04

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrioventricular Nodal Reentry Tachycardia Supraventricular Tachycardia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1

Tachycardia

Group Type EXPERIMENTAL

high resolution cartography

Intervention Type PROCEDURE

High-resolution electro-anatomical mapping will be performed in each group with the RHYTHMIA HDx system to obtain an activation and voltage map of the Koch triangle and surrounding areas.

Group 2

Without tachycardia

Group Type ACTIVE_COMPARATOR

high resolution cartography

Intervention Type PROCEDURE

High-resolution electro-anatomical mapping will be performed in each group with the RHYTHMIA HDx system to obtain an activation and voltage map of the Koch triangle and surrounding areas.

Interventions

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high resolution cartography

High-resolution electro-anatomical mapping will be performed in each group with the RHYTHMIA HDx system to obtain an activation and voltage map of the Koch triangle and surrounding areas.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe MAURY, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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CHU de Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe MAURY, MD

Role: CONTACT

5 61 32 33 16 ext. +33

Facility Contacts

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Philippe MAURY

Role: primary

0561323470

Other Identifiers

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RC31/21/0076

Identifier Type: -

Identifier Source: org_study_id

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