Treatment Study of AV Node Reentry Tachycardia

NCT04232371 | Unknown DMC

• 1 other identifier: Pro00011178
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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

Keywords

New Ablation Technique; Standard Ablation Technique

Outcome Measures

Primary Outcomes (1)

• 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: 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 Outcomes (1)

• Secondary End points - Time from start to end of ablation lesion application(s), and total length of procedure.

  During procedure- start to finish

Study Arms (2)

New Ablation Technique

ACTIVE COMPARATOR

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

Standard Ablation Technique

ACTIVE COMPARATOR

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

Procedure: Standard Ablation Technique

Interventions

New Ablation Technique PROCEDURE

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.

New Ablation Technique

Standard Ablation Technique PROCEDURE

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

Standard Ablation Technique

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeffrey Moak: lead
• University of Iowa: collaborator
• University of Wisconsin, Madison: collaborator
• University of Louisville: collaborator
• Memorial Health System: collaborator

Study Sites (5)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Memorial Health System

Hollywood, Florida, 33021, United States

RECRUITING

Univeristy of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

Related Publications (14)

• Philip Saul J, Kanter RJ; WRITING COMMITTEE; Abrams D, Asirvatham S, Bar-Cohen Y, Blaufox AD, Cannon B, Clark J, Dick M, Freter A, Kertesz NJ, Kirsh JA, Kugler J, LaPage M, McGowan FX, Miyake CY, Nathan A, Papagiannis J, Paul T, Pflaumer A, Skanes AC, Stevenson WG, Von Bergen N, Zimmerman F. PACES/HRS expert consensus statement on the use of catheter ablation in children and patients with congenital heart disease: Developed in partnership with the Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Endorsed by the governing bodies of PACES, HRS, the American Academy of Pediatrics (AAP), the American Heart Association (AHA), and the Association for European Pediatric and Congenital Cardiology (AEPC). Heart Rhythm. 2016 Jun;13(6):e251-89. doi: 10.1016/j.hrthm.2016.02.009. Epub 2016 Feb 17. No abstract available.

  PMID: 26899545 BACKGROUND

• Papagiannis J, Beissel DJ, Krause U, Cabrera M, Telishevska M, Seslar S, Johnsrude C, Anderson C, Tisma-Dupanovic S, Connelly D, Avramidis D, Carter C, Kornyei L, Law I, Von Bergen N, Janusek J, Silva J, Rosenthal E, Willcox M, Kubus P, Hessling G, Paul T; Pediatric and Congenital Electrophysiology Society. Atrioventricular Nodal Reentrant Tachycardia in Patients With Congenital Heart Disease: Outcome After Catheter Ablation. Circ Arrhythm Electrophysiol. 2017 Jul;10(7):e004869. doi: 10.1161/CIRCEP.116.004869. Epub 2017 Jul 7.

  PMID: 28687669 BACKGROUND

• Markowitz SM, Lerman BB. A contemporary view of atrioventricular nodal physiology. J Interv Card Electrophysiol. 2018 Aug;52(3):271-279. doi: 10.1007/s10840-018-0392-5. Epub 2018 Jun 16.

  PMID: 29909540 BACKGROUND

• Lee PC, Chen SA, Hwang B. Atrioventricular node anatomy and physiology: implications for ablation of atrioventricular nodal reentrant tachycardia. Curr Opin Cardiol. 2009 Mar;24(2):105-12. doi: 10.1097/HCO.0b013e328323d83f.

  PMID: 19225293 BACKGROUND

• Malloy L, Law IH, Von Bergen NH. Voltage mapping for slow-pathway visualization and ablation of atrioventricular nodal reentry tachycardia in pediatric and young adult patients. Pediatr Cardiol. 2014 Jan;35(1):103-7. doi: 10.1007/s00246-013-0748-7. Epub 2013 Jul 20.

  PMID: 23872907 BACKGROUND

• Van Aartsen A, Law IH, Maldonado JR, Von Bergen NH. Propagation Mapping Wave Collision Correlates to the Site of Successful Ablation During Voltage Mapping in Atrioventricular Nodal Reentry Tachycardia. J Innov Card Rhythm Manag. 2017 Sep 15;8(9):2836-2842. doi: 10.19102/icrm.2017.080905. eCollection 2017 Sep.

  PMID: 32494469 BACKGROUND

• Collins KK, Dubin AM, Chiesa NA, Avasarala K, Van Hare GF. Cryoablation versus radiofrequency ablation for treatment of pediatric atrioventricular nodal reentrant tachycardia: initial experience with 4-mm cryocatheter. Heart Rhythm. 2006 May;3(5):564-70. doi: 10.1016/j.hrthm.2006.01.026. Epub 2006 Feb 28.

  PMID: 16648062 BACKGROUND

• Kammeraad J, Udink ten Cate F, Simmers T, Emmel M, Wittkampf FH, Sreeram N. Radiofrequency catheter ablation of atrioventricular nodal reentrant tachycardia in children aided by the LocaLisa mapping system. Europace. 2004 May;6(3):209-14. doi: 10.1016/j.eupc.2004.02.004.

  PMID: 15121072 BACKGROUND

• Kriebel T, Bertram H, Windhagen-Mahnert B, Bokenkamp R, Kaulitz R, Rohloff A, Peuster M, Hausdorf G, Paul T. [Atrioventricular nodal reentry tachycardia in children: curative treatment by high frequency catheter ablation]. Z Kardiol. 2000 Jun;89(6):538-45. doi: 10.1007/s003920070226. German.

  PMID: 10929439 BACKGROUND

• Rhodes LA, Wieand TS, Vetter VL. Low temperature and low energy radiofrequency modification of atrioventricular nodal slow pathways in pediatric patients. Pacing Clin Electrophysiol. 1999 Jul;22(7):1071-8. doi: 10.1111/j.1540-8159.1999.tb00572.x.

  PMID: 10456636 BACKGROUND

• Teixeira OH, Balaji S, Case CL, Gillette PC. Radiofrequency catheter ablation of atrioventricular nodal reentrant tachycardia in children. Pacing Clin Electrophysiol. 1994 Oct;17(10):1621-6. doi: 10.1111/j.1540-8159.1994.tb02355.x.

  PMID: 7800563 BACKGROUND

• Papagiannis J, Papadopoulou K, Rammos S, Katritsis D. Cryoablation versus radiofrequency ablation for atrioventricular nodal reentrant tachycardia in children: long-term results. Hellenic J Cardiol. 2010 Mar-Apr;51(2):122-6.

  PMID: 20378513 BACKGROUND

• PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.

  BACKGROUND

• Chow, S.C.; Shao, J.; Wang, H. 2003. Sample Size Calculations in Clinical Research. Marcel Dekker. New York.

  BACKGROUND

MeSH Terms

Conditions

Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Moak

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Moak

CONTACT

2024765707; JMOAK@childrensnational.org

Sarah Litt

CONTACT

2024765707; slitt@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Electrophysiology and Pacing, Principal Investigator, Clinical Professor

Model Details: Patients will be randomized within each participating center, not by center, into study groups: 1. 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. 2. Standard Ablation Technique - ablation performed using the traditional anatomical / electrogram guided ablation approach. Randomization will occur through a module in Redcap.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 18, 2020
• Study Start: July 15, 2020
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

US (5)