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

NCT05296954 | Recruiting

• 1 other identifier: RC31/21/0076
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrioventricular Nodal Reentry Tachycardia; Supraventricular Tachycardia

Keywords

Voltage mapping; Atrioventricular node mapping

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

Tachycardia

Procedure: high resolution cartography

Group 2

ACTIVE COMPARATOR

Without tachycardia

Procedure: high resolution cartography

Interventions

high resolution cartography 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 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal Reentry; Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Tachycardia, Reciprocating; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe MAURY, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe MAURY, MD

CONTACT

5 61 32 33 16; maury.p@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 25, 2022
• Study Start: February 4, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)