High-density Activation Mapping of the Slow Pathwayto Guide Catheter Ablation in Patients With Typical Atrioventricular Nodal Reentrant Tachycardia

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

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.

Study Overview

• Status: Completed
• Conditions: Supraventricular Tachycardia; Atrioventricular Nodal Re Entrant Tachycardia
• Intervention / Treatment: Device: Description of Slow pathway signals to facilitate ablation

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08005
    • Jesús Ignacio Jiménez López

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients > 18 yo with AVNRT observed after electrophysiological study

Exclusion Criteria:

• Patients < 18 yo

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with atrioventricular node reentrant tachycardia; Patient with documented AVNRT and fragmented/slow conduction zones observed in a 3D high density mapping	Device: Description of Slow pathway signals to facilitate ablation; 3D endocardial mapping in order to identify slow pathway signals and abolish or modificate them after radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of AVNRT relapses	Number of patients with absence of relapses after 1 month of the electrophysiological study	one month
Percentage of patient without AVNRT reinduction after procedure	Percentage of patients without tachycardia induction after radiofrequency applications protocol	One day

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Investigators: Principal Investigator: Jesús Ignacio Jimenez López, MD, Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia, Reciprocating; Tachycardia; Tachycardia, Supraventricular; Tachycardia, Atrioventricular Nodal Reentry
• Other Study ID Numbers: CEIm 2022/10521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be register with RED CAP

Drug and device information, study documents

• 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