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

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ClinicalTrials.gov Identifier: NCT05531903
Recruitment Status : Not yet recruiting
First Posted : September 8, 2022
Last Update Posted : September 8, 2022
Sponsor:
Information provided by (Responsible Party):
Jesus Ignacio Jimenez Lopez, Parc de Salut Mar

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.

Condition or disease Intervention/treatment Phase
Supraventricular Tachycardia Atrioventricular Nodal Re Entrant Tachycardia Device: Description of Slow pathway signals to facilitate ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 15, 2022
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : February 1, 2023

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




Primary Outcome Measures :
  1. Absence of reinduction of AVNRT after abolition of fragmented/slow conduction signals [ Time Frame: one day ]
    Number of patients with absence of fragmented/slow conduction signals observed during sinus rhythm or atrial pacing after radiofrequency application


Secondary Outcome Measures :
  1. Absence of AVNRT relapses [ Time Frame: one month ]
    Number of patients with absence of relapses after 1 month of the electrophysiological study

  2. Percentage of patient without AVNRT reinduction after procedure [ Time Frame: One day ]
    Percentage of patients without tachycardia induction after radiofrequency applications protocol



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > 18 yo with AVNRT observed after electrophysiological study

Exclusion Criteria:

  • Patients < 18 yo

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05531903


Contacts
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Contact: Jesús Ignacio JL Jimenez López, MD 34 680714927 jjimenezlopez@psmar.cat
Contact: Ermengol VG Valles Gras, MD PhD 34 666437038 evalles@psmar.cat

Locations
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Spain
Jesús Ignacio Jiménez López
Barcelona, Spain, 08005
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: Jesús Ignacio Jimenez López, MD Parc de Salut Mar
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Responsible Party: Jesus Ignacio Jimenez Lopez, Principal investigator, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT05531903    
Other Study ID Numbers: CEIm 2022/10521
First Posted: September 8, 2022    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be register with RED CAP

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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
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Supraventricular
Tachycardia, Atrioventricular Nodal Reentry
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Tachycardia, Reciprocating