Study Summary
This trial compares two methods for correcting a heart condition called AVNRT. The first, called the New Ablation Technique, uses low voltage and wave front collision mapping. The second, called the Standard Ablation Technique, uses an anatomical/electrogram approach.
Eligible Conditions
- Supraventricular Tachycardia
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: During procedure- start to finish
During procedure- start to finish
Primary end point - Number of lesions needed to achieve modification of slow AV nodal pathway
Secondary End points - Time from start to end of ablation lesion application(s), and total length of procedure.
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Standard Ablation Technique
1 of 2
New Ablation Technique
1 of 2
Active Control
300 Total Participants · 2 Treatment Groups
Primary Treatment: Standard Ablation Technique · No Placebo Group · N/A
Standard Ablation Technique
Procedure
ActiveComparator Group · 1 Intervention: Standard Ablation Technique · Intervention Types: ProcedureNew Ablation Technique
Procedure
ActiveComparator Group · 1 Intervention: New Ablation Technique · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during procedure- start to finish
Who is running the clinical trial?
Jeffrey MoakLead Sponsor
1 Previous Clinical Trials
870 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,102 Previous Clinical Trials
2,900,103 Total Patients Enrolled
University of LouisvilleOTHER
322 Previous Clinical Trials
73,595 Total Patients Enrolled
Memorial Health SystemOTHER
7 Previous Clinical Trials
20,511 Total Patients Enrolled
University of IowaOTHER
425 Previous Clinical Trials
879,269 Total Patients Enrolled
Eligibility Criteria
Age < 65 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Papagiannis, John, Daniel Joseph Beissel, Ulrich Krause, Michel Cabrera, Marta Telishevska, Stephen Seslar, Christopher Johnsrude, et al.. 2017. “Atrioventricular Nodal Reentrant Tachycardia in Patients with Congenital Heart Disease”. Circulation: Arrhythmia and Electrophysiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circep.116.004869.
- Kammeraad, J. 2004. “Radiofrequency Catheter Ablation of Atrioventricular Nodal Reentrant Tachycardia in Children Aided by the Localisa Mapping System”. Europace. Oxford University Press (OUP). doi:10.1016/j.eupc.2004.02.004.
- RHODES, LARRY A., TAMMY S. WIEAND, and VICTORIA L. VETTER. 1999. “Low Temperature and Low Energy Radiofrequency Modification of Atrioventricular Nodal Slow Pathways in Pediatric Patients”. Pacing and Clinical Electrophysiology. Wiley. doi:10.1111/j.1540-8159.1999.tb00572.x.
- Chan, N. Y., N. S. Mok, C. L. Lau, Y. K. Lo, C. C. Choy, S. T. Lau, and Y. C. Choi. 2009. “Treatment of Atrioventricular Nodal Re-entrant Tachycardia by Cryoablation with a 6 Mm-tip Catheter Vs. Radiofrequency Ablation”. Europace. Oxford University Press (OUP). doi:10.1093/europace/eup121.
- Van Aartsen, Amy, Ian Law, Jennifer Maldonado, and Nicholas Von Bergen. 2017. “Propagation Mapping Wave Collision Correlates to the Site of Successful Ablation During Voltage Mapping in Atrioventricular Nodal Reentry Tachycardia”. The Journal of Innovations in Cardiac Rhythm Management. MediaSphere Medical LLC. doi:10.19102/icrm.2017.080905.
- Lee, Pi-Chang, Shih-Ann Chen, and Betau Hwang. 2009. “Atrioventricular Node Anatomy and Physiology: Implications for Ablation of Atrioventricular Nodal Reentrant Tachycardia”. Current Opinion in Cardiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/hco.0b013e328323d83f.
- Philip Saul, J., Ronald J. Kanter, Dominic Abrams, Sam Asirvatham, Yaniv Bar-Cohen, Andrew D. Blaufox, Bryan Cannon, et al.. 2016. “PACES/HRS Expert Consensus Statement on the Use of Catheter Ablation in Children and Patients with Congenital Heart Disease”. Heart Rhythm. Elsevier BV. doi:10.1016/j.hrthm.2016.02.009.
- TEIXEIRA, OTTO H.P., SESHADRI BALAJI, CHRISTOPHER L. CASE, and PAUL C. GILLETTE. 1994. “Radiofrequency Catheter Ablation of Atrioventricular Nodal Reentrant Tachycardia in Children”. Pacing and Clinical Electrophysiology. Wiley. doi:10.1111/j.1540-8159.1994.tb02355.x.
- Markowitz, Steven M., and Bruce B. Lerman. 2018. “A Contemporary View of Atrioventricular Nodal Physiology”. Journal of Interventional Cardiac Electrophysiology. Springer Science and Business Media LLC. doi:10.1007/s10840-018-0392-5.
- Malloy, Lindsey, Ian H. Law, and Nicholas H. Von Bergen. 2013. “Voltage Mapping for Slow-pathway Visualization and Ablation of Atrioventricular Nodal Reentry Tachycardia in Pediatric and Young Adult Patients”. Pediatric Cardiology. Springer Science and Business Media LLC. doi:10.1007/s00246-013-0748-7.
- Collins, Kathryn K., Anne M. Dubin, Nancy A. Chiesa, Kishor Avasarala, and George F. Van Hare. 2006. “Cryoablation Versus Radiofrequency Ablation for Treatment of Pediatric Atrioventricular Nodal Reentrant Tachycardia: Initial Experience with 4-mm Cryocatheter”. Heart Rhythm. Elsevier BV. doi:10.1016/j.hrthm.2006.01.026.
- Kriebel, T., H. Bertram, B. Windhagen-Mahnert, R. Bökenkamp, R. Kaulitz, A. Rohloff, M. Peuster, G. Hausdorf, and T. Paul. 2000. “Av-knoten-reentry-tachykardien im kindesalter: kurative behandlung durch hochfrequenzstromablation”. Zeitschrift für kardiologie. Springer Science and Business Media LLC. doi:10.1007/s003920070226.
- Chow, S.C.; Shao, J.; Wang, H. 2003. Sample Size Calculations in Clinical Research. Marcel Dekker. New York.
- PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Jeffrey Moak 2020. "Treatment Study of AV Node Reentry Tachycardia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04232371.
Frequently Asked Questions
How many individuals have joined the experiment thus far?
"This clinical trial necessitates the involvement of 300 patients that fit within their desired criteria. Patients will be able to join from multiple sites, including Univeristy of Iowa in Iowa City and University of Louisville in Louisville, Kentucky." - Anonymous Online Contributor
Unverified Answer
In what geographic areas is this clinical research being conducted?
"This particular medical trial is recruiting patients at the University of Iowa in Iowa City, the University of Louisville in Louisville, and the Univeristy of Wisconsin located in Madison. Additionally, there are 5 other locations participating." - Anonymous Online Contributor
Unverified Answer