Back to resultsHigh-density Activation Mapping of the Slow Pathwayto Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia
Primary Purpose
Supraventricular Tachycardia, Atrioventricular Nodal Re Entrant Tachycardia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Description of Slow pathway signals to facilitate ablation
Sponsored by
About this trial
This is an interventional treatment trial for Supraventricular Tachycardia
Eligibility Criteria
Inclusion Criteria:
- Patients > 18 yo with AVNRT observed after electrophysiological study
Exclusion Criteria:
- Patients < 18 yo
Sites / Locations
- Jesús Ignacio Jiménez López
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with atrioventricular node reentrant tachycardia
Arm Description
Patient with documented AVNRT and fragmented/slow conduction zones observed in a 3D high density mapping
Outcomes
Primary Outcome Measures
Absence of reinduction of AVNRT after abolition of fragmented/slow conduction signals
Number of patients with absence of fragmented/slow conduction signals observed during sinus rhythm or atrial pacing after radiofrequency application
Secondary Outcome Measures
Absence of AVNRT relapses
Number of patients with absence of relapses after 1 month of the electrophysiological study
Percentage of patient without AVNRT reinduction after procedure
Percentage of patients without tachycardia induction after radiofrequency applications protocol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05531903
Brief Title
High-density Activation Mapping of the Slow Pathwayto Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia
Official Title
High-density Activation Mapping of the Slow Pathway During Sinus Rhythm: a New and Simple Method to Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Atrioventricular nodal reentrant tachycardia (AVNRT) is the most common supraventricular tachycardia inducible during an electrophysiological study. Although ablative therapy proved to be the treatment of choice, little is known about the components of the tachycardia circuit. The aim of this study is to detect the presence and patterns of specific electrograms representing slow pathway (SP) potentials and to explore Koch's triangle pattern activation during sinus rhythm and/or atrial extraestimulus with a high-density mapping catheter in an attempt to clarify a fast and safety catheter ablation strategy. We hypothesized that, in patients with dual atrioventricular nodal physiology, during sinus rhythm (SR), high-density mapping (HDM) catheters could identify the SP signals, making possible to delineate small areas of slow conduction associated to abnormal electrograms on Koch's triangle. On a second step, radiofrequency (RF) applications safety guided by the HDM obtained with this method, should interrupt the circuit far from the His region. Finally, SP signals should disappear after the RF procedure when performing a new 3D HDM. A control group of patients without AVN dual physiology should show absence of fragmented/slow conduction zones.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia, Atrioventricular Nodal Re Entrant Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group of intervention. A control group with absence of dual AVN phisiology to check lack of abnormal fragmented/slow conduction confluent zones.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with atrioventricular node reentrant tachycardia
Arm Type
Experimental
Arm Description
Patient with documented AVNRT and fragmented/slow conduction zones observed in a 3D high density mapping
Intervention Type
Device
Intervention Name(s)
Description of Slow pathway signals to facilitate ablation
Intervention Description
3D endocardial mapping in order to identify slow pathway signals and abolish or modificate them after radiofrequency ablation
Primary Outcome Measure Information:
Title
Absence of reinduction of AVNRT after abolition of fragmented/slow conduction signals
Description
Number of patients with absence of fragmented/slow conduction signals observed during sinus rhythm or atrial pacing after radiofrequency application
Time Frame
one day
Secondary Outcome Measure Information:
Title
Absence of AVNRT relapses
Description
Number of patients with absence of relapses after 1 month of the electrophysiological study
Time Frame
one month
Title
Percentage of patient without AVNRT reinduction after procedure
Description
Percentage of patients without tachycardia induction after radiofrequency applications protocol
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients > 18 yo with AVNRT observed after electrophysiological study
Exclusion Criteria:
Patients < 18 yo
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesús Ignacio JL Jimenez López, MD
Phone
34 680714927
Email
jjimenezlopez@psmar.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Ermengol VG Valles Gras, MD PhD
Phone
34 666437038
Email
evalles@psmar.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesús Ignacio Jimenez López, MD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jesús Ignacio Jiménez López
City
Barcelona
ZIP/Postal Code
08005
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be register with RED CAP
Learn more about this trial
High-density Activation Mapping of the Slow Pathwayto Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia
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