Treatment Study of AV Node Reentry Tachycardia (AVNRT)

July 26, 2022 updated by: Jeffrey Moak

Randomized Clinical Trial for Treatment of Atrioventricular Nodal Reentry Tachycardia (AVNRT): Low Voltage and Wave Front Collision Mapping vs. Anatomic/Electrogram Approach to Slow AV Nodal Pathway Ablation

Compare the effectiveness and safety of two techniques for modification of slow AV nodal pathway conduction underlying AVNRT: 1) New Ablation Technique, low voltage and wave front collision mapping vs. 2) the Standard Ablation Technique, an anatomical/electrogram approach.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Supraventricular tachycardia (SVT) is an arrhythmia condition that affects 1 in 250 to 1/1000 children. While there are many different mechanisms for SVT, having an additional electrical pathway in the heart is the most common underlying reason. The extra electrical pathway may be in the form of an accessory AV pathway that bridges the atrium and ventricle or a slowing conducting pathway in the AV nodal region. SVT may cause significant disability from the sudden unexpected rapid increase in heart rate. Symptoms associated with SVT may include dizziness, syncope, shortness of breath, chest pain and exercise intolerance. Prolonged episodes that do not self terminate may require the patient to be evaluated in an emergency room. If left untreated, SVT may result in congestive heart failure and the potential for sudden cardiac arrest.

Catheter based ablation involves the localized application of energy to the site responsible for the SVT, effecting a permanent cure. Ablation has become the primary mode for treating patients with SVT. Ablation is achieved by the focal and limited application of energy (either heating the tissue to temperatures beyond viability, radiofrequency energy (RF)) or cooling the tissue (cryoablation)) to functionally destroy the underlying myocardial tissue. Both energy sources are very effective in achieving this end point, and the elimination of arrhythmias.

SVT involving the AV node, known as AV node reentry tachycardia (AVNRT), is one of the most common forms of this arrhythmia. While a conceptual construct for understanding AV node reentry tachycardia has evolved over the years, the subtleties of the exact pathophysiologic mechanism leading to its occurrence is undefined. Most of the medical literature endorses the concept of two (dual) inputs into the compact AV node. Circus movement or reentry incorporating the fast and slow pathways (two AV nodal pathways) is thought to facilitate this form of SVT. Current ablation practice is centered on modification of the slow AV nodal pathway conduction, leaving the fast AV nodal pathway intact so as to allow for a normal conduction interval between the atrium and ventricule, the PR interval.

Approaches for ablation of the slow AV nodal pathway differ among pediatric centers. The two most used techniques for ablation of the slow AV nodal pathway to prevent AV nodal reentry tachycardia involve: 1) an anatomical/electrogram approach based on physical position of the ablation catheter and the electrogram morpholog (Standard Technique), and 2) mapping of electrogram voltage in the triangle of Koch to define an area of low voltage with assessment of the site for wave front collision of electrical activity traveling over the fast and slow AV nodal pathways (New Technique).

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Hospital
        • Contact:
          • Jeffrey P Moak, MD
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Health System
        • Contact:
          • Orhan U kilinc, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Univeristy of Iowa
        • Contact:
          • Ian H Law, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Contact:
          • Christopher L Johnsrude, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin
        • Contact:
          • Nicholas H Von Bergen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Weight >15 kg
  2. Age < 21 years old
  3. Simple CHD acceptable to enroll (Table 1):

Table 1. Diagnoses in Adult Patients with Simple Congenital Heart Disease

  • Isolated congenital aortic valve disease
  • Isolated congenital mitral valve disease (eg, except parachute valve, cleft leaflet)
  • Small atrial septal defect
  • Isolated small ventricular septal defect (no associated lesions)
  • Mild pulmonary stenosis
  • Small patent ductus arteriosus
  • Repaired conditions
  • Previously ligated or occluded ductus arteriosus
  • Repaired secundum or sinus venosus atrial septal defect without residua
  • Repaired ventricular septal defect without residua

Exclusion Criteria:

  1. Additional mechanism(s) for SVT in addition to AV nodal reentry tachycardia.
  2. Moderate or Complex Congenital Heart Disease, see tables 2 and 3.

Table 2. Diagnoses in Adult Patients with Congenital Heart Disease of Moderate Complexity

  • Aorto-left ventricular fistulas
  • Anomalous pulmonary venous drainage, partial or total
  • Atrioventricular septal defects (partial or complete)
  • Coarctation of the aorta
  • Ebstein's anomaly
  • Infundibular right ventricular outflow obstruction of significance
  • Ostium primum atrial septal defect
  • Patent ductus arteriosus (not closed)
  • Pulmonary valve regurgitation (moderate to severe)
  • Pulmonary valve stenosis (moderate to severe)
  • Sinus of Valsalva fistula/aneurysm
  • Sinus venosus atrial septal defect
  • Subvalvular AS or SupraAS (except HOCM)
  • Tetralogy of Fallot
  • Ventricular septal defect with:
  • Absent valve or valves
  • Aortic regurgitation
  • Coarctation of the aorta
  • Mitral disease
  • Right ventricular outflow tract obstruction
  • Straddling tricuspid/mitral valve
  • Subaortic stenosis

Table 3. Types of Adult Congenital Heart Disease - Severe Complexity

  • Conduits, valved or nonvalved
  • Cyanotic congenital heart (all forms)
  • Double-outlet ventricle
  • Eisenmenger syndrome
  • Fontan procedure
  • Mitral atresia
  • Single ventricle (also called double inlet or outlet, common, or primitive)
  • Pulmonary atresia (all forms)
  • Pulmonary vascular obstructive disease
  • Transposition of the great arteries
  • Tricuspid atresia
  • Truncus arteriosus/hemitruncus
  • Other abnormalities of atrioventricular or ventriculoarterial connection not included above (ie, crisscross heart, isomerism, heterotaxy syndromes, ventricular inversion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: New Ablation Technique
Will undergo ablation using voltage mapping and triangle of Koch propagation wave collision mapping. Ablation will be performed at or slightly above the site of wave front collision.
Procedure: New Ablation Technique
Patient will undergo ablation using voltage mapping and triangle of Koch propagation wave collision mapping. Ablation will be performed at or slightly above the site of wave front collision.
Active Comparator: Standard Ablation Technique
Ablation performed using the traditional anatomical / electrogram guided ablation approach.
Procedure: Standard Ablation Technique
Ablation performed using the traditional anatomical / electrogram guided ablation approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary end point - Number of lesions needed to achieve modification of slow AV nodal pathway
Time Frame: During procedure- start to finish

Number of ablation lesion needed to achieve modification of slow AV nodal pathway conduction underlying AVNRT as defined by one of the following:

  1. Absent SVT induction
  2. Loss of slow pathway function as defined by no jumps (discontinuity in AV conduction curve) or unable to sustain PR > RR during rapid atrial pacing
  3. Persistence of dual pathway physiology with no echo beat
  4. Persistence of dual pathway physiology with single echo beat
During procedure- start to finish

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary End points - Time from start to end of ablation lesion application(s), and total length of procedure.
Time Frame: During procedure- start to finish
  1. Time from start to end of ablation lesion application(s)
  2. Procedure time (sheath in to time of final sheath removal)
During procedure- start to finish

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeffrey Moak

Collaborators

University of Iowa
University of Wisconsin, Madison
University of Louisville
Memorial Health System

Investigators

  • Principal Investigator: Jeffrey Moak, Children's National Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2020

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00011178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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