Supraventricular TachycardiaAVNRTNCT04232371
Treatment Study of AV Node Reentry Tachycardia
A study testing New Ablation Technique and Standard Ablation Technique in people with Supraventricular Tachycardia, run by Jeffrey Moak at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Supraventricular Tachycardia
- What is being tested?
- New Ablation Technique and Standard Ablation Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Jul 2020to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
- 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)
Show all 39Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Memorial Health System
Hollywood, Florida, 33021
Orhan U kilinc, MD
- Recruiting
Univeristy of Iowa
Iowa City, Iowa, 52242
Ian H Law, MD
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Christopher L Johnsrude, MD
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Nicholas H Von Bergen, MD
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Jeffrey P Moak, MD
About this study
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
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.
Read the 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).
- Conditions
- Supraventricular Tachycardia
- Being tested
- New Ablation Technique, Standard Ablation Technique
- Keywords
- New Ablation Technique, Standard Ablation Technique
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Ablation TechniqueProcedure or surgery
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 TechniqueProcedure or surgery
Ablation performed using the traditional anatomical / electrogram guided ablation approach.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: New Ablation Technique |
| Standard Ablation Technique | Active comparator | Ablation performed using the traditional anatomical / electrogram guided ablation approach. Receives: Procedure: Standard Ablation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
- Time from start to end of ablation lesion application(s)
- Procedure time (sheath in to time of final sheath removal)
Measured: During procedure- start to finish
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start15 Jul 2020
- Primary completionJan 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeffrey Moak
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of Wisconsin, Madison, University of Louisville, Memorial Health System
- Responsible party
- Sponsor-investigator, Jeffrey Moak, Children's National Research Institute
- Investigators
- Jeffrey Moak, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232371
- Sponsor's protocol ID
- Pro00011178
- Acronym
- AVNRT
- Status last verified
- Jul 2022
- First submitted
- 6 Jan 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26899545Papagiannis 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.
PubMed 28687669Markowitz 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.
PubMed 29909540Lee 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.
PubMed 19225293Malloy 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.
PubMed 23872907Van 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.
PubMed 32494469Collins 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.
PubMed 16648062Kammeraad 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.
PubMed 15121072Kriebel 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.
PubMed 10929439Rhodes 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.
PubMed 10456636Teixeira 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.
PubMed 7800563Papagiannis 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.
PubMed 20378513PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
Chow, S.C.; Shao, J.; Wang, H. 2003. Sample Size Calculations in Clinical Research. Marcel Dekker. New York.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04232371
- Acronym / sponsor ID
- AVNRT / Pro00011178
- Conditions
- Supraventricular Tachycardia
- Keywords
- New Ablation Technique, Standard Ablation Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jeffrey MoakUniversity, hospital or other
- Collaborators
- University of Iowa, University of Wisconsin, Madison, University of Louisville, Memorial Health System
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| New Ablation Technique | Active comparator | Procedure: New Ablation TechniqueWill 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 | Active comparator | Procedure: Standard Ablation TechniqueAblation performed using the traditional anatomical / electrogram guided ablation approach. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (39 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Ablation TechniquePatient 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 or surgery | New Ablation Technique |
| Standard Ablation TechniqueAblation performed using the traditional anatomical / electrogram guided ablation approach. | Procedure or surgery | Standard Ablation Technique |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 26899545Philip 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.
- Background: PubMed 28687669Papagiannis 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.
- Background: PubMed 29909540Markowitz 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.
- Background: PubMed 19225293Lee 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.
- Background: PubMed 23872907Malloy 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.
- Background: PubMed 32494469Van 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.
- Background: PubMed 16648062Collins 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.
- Background: PubMed 15121072Kammeraad 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.
- Background: PubMed 10929439Kriebel 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.
- Background: PubMed 10456636Rhodes 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.
- Background: PubMed 7800563Teixeira 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.
- Background: PubMed 20378513Papagiannis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Moak principal investigator
Children's National Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Ablation Technique and Standard Ablation Technique in people with Supraventricular Tachycardia, run by Jeffrey Moak at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Moak (2024765707, JMOAK@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04232371, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.