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Clinical Trials/NCT05296954
NCT05296954RecruitingNot Applicable

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

University Hospital, Toulouse1 site in 1 country20 target enrollmentStarted: February 4, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Determine the precise location of the AV node

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Group 1

Experimental

Tachycardia

Intervention: high resolution cartography (Procedure)

Group 2

Active Comparator

Without tachycardia

Intervention: high resolution cartography (Procedure)

Outcomes

Primary Outcomes

Determine the precise location of the AV node

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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