Recruiting

New Ablation Technique vs. Standard Ablation Technique

Sponsor:

Jeffrey Moak

Code:

NCT04232371

Conditions

Supraventricular Tachycardia

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

New Ablation Technique

Standard Ablation Technique

Study Details

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.

Conditions

Supraventricular Tachycardia

Study ID

NCT04232371

Start date

Jul 15, 2020

Status verified date

Jul, 2022

Completion date

Mar, 2023

Anticipated

Primary completion date

Jan, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Standard Ablation Technique

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

Interventions

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.

Standard Ablation Technique

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

Primary outcome measure

  • Primary end point - Number of lesions needed to achieve modification of slow AV nodal pathway [ Time Frame: During procedure- start to finish ]

Central Contacts and Locations

Central contacts

Jeffrey Moak

2024765707JMOAK@childrensnational.org

Sarah Litt

2024765707slitt@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington, District of Columbia, United States, 20010

Memorial Health System

Recruiting

Hollywood, Florida, United States, 33021

Univeristy of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

Jeffrey Moak

Last update posted

Jul 28, 2022

Last verified

Jul, 2022

Keywords

  • New Ablation Technique
  • Standard Ablation Technique

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jeffrey Moak on 2022-07-28.