KOCH-MAPPING: Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping.

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Recruiting

CT.gov ID

NCT05296954

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrioventricular Nodal Reentry Tachycardia Supraventricular Tachycardia	Procedure: high resolution cartography	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 4, 2022

Anticipated Primary Completion Date :

Nov 4, 2022

Anticipated Study Completion Date :

Nov 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Tachycardia	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.
Active Comparator: Group 2 Without tachycardia	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.

Arm

Intervention/Treatment

Experimental: Group 1

Tachycardia

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.

Active Comparator: Group 2

Without tachycardia

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.

Outcome Measures

Primary Outcome Measures

Determine the precise location of the AV node [7 months]
Determine the precise location of the AV node with off-line additional filter changes and additional techniques (conduction velocities, isochrones and dV/dt).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Toulouse	Toulouse		France

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Philippe MAURY, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT05296954

Other Study ID Numbers:

RC31/21/0076

First Posted:

Mar 25, 2022

Last Update Posted:

Mar 25, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Toulouse

Voltage mapping

Atrioventricular node mapping

Additional relevant MeSH terms:

Tachycardia

Tachycardia, Supraventricular

Tachycardia, Atrioventricular Nodal Reentry

Study Results

No Results Posted as of Mar 25, 2022