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Treatment Study of AV Node Reentry Tachycardia (AVNRT)

Primary Purpose

Supraventricular Tachycardia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New Ablation Technique
Standard Ablation Technique
Sponsored by
Jeffrey Moak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supraventricular Tachycardia focused on measuring New Ablation Technique, Standard Ablation Technique

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Children's National HospitalRecruiting
  • Memorial Health SystemRecruiting
  • Univeristy of IowaRecruiting
  • University of LouisvilleRecruiting
  • University of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

New Ablation Technique

Standard Ablation Technique

Arm Description

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.

Ablation performed using the traditional anatomical / electrogram guided ablation approach.

Outcomes

Primary Outcome Measures

Primary end point - Number of lesions needed to achieve modification of slow AV nodal pathway
Number of ablation lesion needed to achieve modification of slow AV nodal pathway conduction underlying AVNRT as defined by one of the following: Absent SVT induction 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 Persistence of dual pathway physiology with no echo beat Persistence of dual pathway physiology with single echo beat

Secondary Outcome Measures

Secondary End points - Time from start to end of ablation lesion application(s), and total length of procedure.
Time from start to end of ablation lesion application(s) Procedure time (sheath in to time of final sheath removal)

Full Information

First Posted
January 6, 2020
Last Updated
July 26, 2022
Sponsor
Jeffrey Moak
Collaborators
University of Iowa, University of Wisconsin, Madison, University of Louisville, Memorial Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04232371
Brief Title
Treatment Study of AV Node Reentry Tachycardia
Acronym
AVNRT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey Moak
Collaborators
University of Iowa, University of Wisconsin, Madison, University of Louisville, Memorial Health System

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardia
Keywords
New Ablation Technique, Standard Ablation Technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized within each participating center, not by center, into study groups: 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. Standard Ablation Technique - ablation performed using the traditional anatomical / electrogram guided ablation approach. Randomization will occur through a module in Redcap.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
New Ablation Technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Ablation Technique
Arm Type
Active Comparator
Arm Description
Ablation performed using the traditional anatomical / electrogram guided ablation approach.
Intervention Type
Procedure
Intervention Name(s)
New Ablation Technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Ablation Technique
Intervention Description
Ablation performed using the traditional anatomical / electrogram guided ablation approach.
Primary Outcome Measure Information:
Title
Primary end point - Number of lesions needed to achieve modification of slow AV nodal pathway
Description
Number of ablation lesion needed to achieve modification of slow AV nodal pathway conduction underlying AVNRT as defined by one of the following: Absent SVT induction 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 Persistence of dual pathway physiology with no echo beat Persistence of dual pathway physiology with single echo beat
Time Frame
During procedure- start to finish
Secondary Outcome Measure Information:
Title
Secondary End points - Time from start to end of ablation lesion application(s), and total length of procedure.
Description
Time from start to end of ablation lesion application(s) Procedure time (sheath in to time of final sheath removal)
Time Frame
During procedure- start to finish

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Weight >15 kg Age < 21 years old 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: Additional mechanism(s) for SVT in addition to AV nodal reentry tachycardia. 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Moak
Phone
2024765707
Email
JMOAK@childrensnational.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Litt
Phone
2024765707
Email
slitt@childrensnational.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Moak
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey P Moak, MD
Facility Name
Memorial Health System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orhan U kilinc, MD
Facility Name
Univeristy of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian H Law, MD
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher L Johnsrude, MD
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas H Von Bergen, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26899545
Citation
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Treatment Study of AV Node Reentry Tachycardia

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