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CompletedNCT05531903Updated Apr 12, 2024

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

An interventional study of Description of Slow pathway signals to facilitate ablation in Supraventricular Tachycardia and Atrioventricular Nodal Re Entrant Tachycardia, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Parc de Salut Mar · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2023, 3 years 2 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
119
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Supraventricular Tachycardia
  • Atrioventricular Nodal Re Entrant Tachycardia
03

In context

Tachycardia

623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.

This study's enrollment of 119 is above the median of 64 across 379 interventional studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

Parc de Salut Mar is the lead sponsor of 180 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients > 18 yo with AVNRT observed after electrophysiological study

Exclusion criteria

Exclusion Criteria:

  • Patients \< 18 yo
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
119 participants (actual)

Study arms

  • 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

Interventions

  • DeviceDescription 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

06

What researchers measure

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

    Time frame: one day

Secondary outcomes

  1. Absence of AVNRT relapses

    Number of patients with absence of relapses after 1 month of the electrophysiological study

    Time frame: one month

  2. Percentage of patient without AVNRT reinduction after procedure

    Percentage of patients without tachycardia induction after radiofrequency applications protocol

    Time frame: One day

07

Study locations

1 site
  • Jesús Ignacio Jiménez López
    Barcelona, 08005, Spain
08

References and documents

Individual participant data

Plan to share: No — Data will be register with RED CAP

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05531903
Lead sponsor
Parc de Salut Mar
Responsible party
Jesus Ignacio Jimenez Lopez (Principal investigator, Parc de Salut Mar) — Principal investigator
First posted
Sep 8, 2022
Start date
Oct 15, 2022
Primary completion
Jul 30, 2023
Completion
Sep 1, 2023
Last update
Apr 12, 2024

Study contacts

Jesús Ignacio Jimenez López, MD
principal investigator · Parc de Salut Mar

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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