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

NCT05531903 | Completed FDA Device

• 1 other identifier: CEIm 2022/10521
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraventricular Tachycardia; Atrioventricular Nodal Re Entrant Tachycardia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Absence of AVNRT relapses

  one month

• Percentage of patient without AVNRT reinduction after procedure

  One day

Study Arms (1)

Patients with atrioventricular node reentrant tachycardia

EXPERIMENTAL

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

Interventions

Description of Slow pathway signals to facilitate ablation DEVICE

3D endocardial mapping in order to identify slow pathway signals and abolish or modificate them after radiofrequency ablation

Patients with atrioventricular node reentrant tachycardia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 yo with AVNRT observed after electrophysiological study

You may not qualify if:

• Patients \< 18 yo

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Jesús Ignacio Jiménez López

Barcelona, 08005, Spain

Location

MeSH Terms

Conditions

Tachycardia, Supraventricular; Tachycardia, Atrioventricular Nodal Reentry

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia, Reciprocating

Study Officials

• Jesús Ignacio Jimenez López, MD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Single group of intervention. A control group with absence of dual AVN phisiology to check lack of abnormal fragmented/slow conduction confluent zones.

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 8, 2022
• Study Start: October 15, 2022
• Primary Completion: July 30, 2023
• Study Completion: September 1, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)