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

Supraventricular Tachycardia Clinical Trial

— KOCH-MAPPING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05296954
• Other study ID #: RC31/21/0076
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Philippe MAURY, MD
• Phone: 5 61 32 33 16
• Email: maury.p[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrioventricular Nodal Reentry Tachycardia
• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Atrioventricular Nodal Reentry
• Tachycardia, Supraventricular

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the precise location of the AV node	Determine the precise location of the AV node with off-line additional filter changes and additional techniques (conduction velocities, isochrones and dV/dt).	7 months