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

Supraventricular Tachycardia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05531903
• Other study ID #: CEIm 2022/10521
• Status: Completed
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2024
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 1, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients > 18 yo with AVNRT observed after electrophysiological study

Exclusion Criteria:

• Patients < 18 yo

Related Conditions & MeSH terms

• Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Atrioventricular Nodal Reentry
• Tachycardia, Supraventricular

Intervention

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

Locations

Country	Name	City	State
Spain	Jesús Ignacio Jiménez López	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absence of AVNRT relapses	Number of patients with absence of relapses after 1 month of the electrophysiological study	one month
Secondary	Percentage of patient without AVNRT reinduction after procedure	Percentage of patients without tachycardia induction after radiofrequency applications protocol	One day