Back to resultsLocalization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping. (KOCH-MAPPING)
Primary Purpose
Atrioventricular Nodal Reentry Tachycardia, Supraventricular Tachycardia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high resolution cartography
Sponsored by
About this trial
This is an interventional other trial for Atrioventricular Nodal Reentry Tachycardia focused on measuring Voltage mapping, Atrioventricular node mapping
Eligibility Criteria
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
Sites / Locations
- CHU de ToulouseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Tachycardia
Without tachycardia
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05296954
First Posted
March 4, 2022
Last Updated
July 21, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT05296954
Brief Title
Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping.
Acronym
KOCH-MAPPING
Official Title
Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping. Feasibility Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Nodal Reentry Tachycardia, Supraventricular Tachycardia
Keywords
Voltage mapping, Atrioventricular node mapping
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Tachycardia
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Without tachycardia
Intervention Type
Procedure
Intervention Name(s)
high resolution cartography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine the precise location of the AV node
Description
Determine the precise location of the AV node with off-line additional filter changes and additional techniques (conduction velocities, isochrones and dV/dt).
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe MAURY, MD
Phone
5 61 32 33 16
Ext
+33
Email
maury.p@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe MAURY, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe MAURY
Phone
0561323470
Email
maury.p@chu-toulouse.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping.
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