Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias
NCT ID: NCT04078685
Last Updated: 2020-09-03
Study Results
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Basic Information
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UNKNOWN
NA
113 participants
INTERVENTIONAL
2018-06-12
2021-03-20
Brief Summary
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Detailed Description
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Multiple studies have demonstrated the importance of adequate catheter-tissue contact in the creation of effective lesions during radiofrequency catheter ablation. The development of contact-force(CF)-sensing catheters have contributed significantly to improve clinical outcomes in atrial fibrillation 3-18. However CF-sensing technology is not used in the ablation of paroxysmal supraventricular tachycardia. Although PSVT ablation with the conventional approach (non-irrigated, non-CF-sensing catheters) is considered a relatively low-risk procedure with fairly high success rate (short-and long-term) 1,2,19, we hypothesize that contact-force sensing can further improve the outcomes of these procedures. Based on the results of studies on atrial fibrillation ablation (mentioned above) we believe that CF-sensing could similarly improve such important parameters as radiofrequency (RF) application number/time, total procedure time, and fluoroscopy time in cases of PSVT ablations, as well. In addition CF-sensing could also further improve acute success/recurrence rates of PSVT ablation, and might also be capable to further diminish complication risk.
Primary Objective:
The primary objective of the present study is to demonstrate the superiority of contact-force-sensing in the ablation of AVNRT and WPW-AVRT as assessed by the improvement in the number and duration of radiofrequency applications compared with the conventional ablation approach.
Secondary Objective:
Secondary objectives of the study are the followings:
* to demonstrate that contact-force-sensing catheters are superior in terms of total procedure duration and fluoroscopy times in the case of AVNRT/WPW-AVRT ablation.
* to show that the use of contact-force sensing catheters is non-inferior to conventional catheters (without contact-force-sensing) in terms of acute/long-term procedural success and procedural safety (major/minor complication rate) of AVNRT/WPW-AVRT ablations.
Study population:
All patients above 18 years without structural heart disease being referred for electrophysiological study and potential treatment with radiofrequency catheter ablation of atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular reentrant tachycardia (AVRT) with manifest (WPW syndrome) or concealed accessory pathways.
Intervention:
One group undergoes manual ablation using standard non-irrigated ablation catheters and the other group undergoes manual ablation with an open-irrigated ablation catheter equipped with CF- sensing (and utilized in a non-irrigated mode during ablation)
Main study parameters/endpoints:
The main study endpoint is the difference in RF application number during the procedures of AVNRT/WPW-AVRT ablation; secondary endpoints are differences in RF application rate, acute success rate, long-term recurrence rate (1 year) major/minor complication rate, and total procedure/fluoroscopy time.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CONVENTIONAL group
Patients with supraventricular tachycardia treated with radiofrequency ablation using a standard (non-contact-force sensing) ablation catheter
Standard catheter ablation
Radiofrequency catheter ablation using a standard ablation catheters: not equipped with contact-force sensing
CONTACT-FORCE group
Patients with supraventricular tachycardia treated with radiofrequency ablation using a Contact-Force-sensing ablation catheter
Contact Force-sensing-based catheter ablation
Radiofrequency catheter ablation using a Contact-Force-sensing ablation catheter
Interventions
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Standard catheter ablation
Radiofrequency catheter ablation using a standard ablation catheters: not equipped with contact-force sensing
Contact Force-sensing-based catheter ablation
Radiofrequency catheter ablation using a Contact-Force-sensing ablation catheter
Eligibility Criteria
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Inclusion Criteria
* Identification of AVNRT or WPW-AVRT (with manifest or concealed accessory pathway) during standard EP study
* Verbal consent to continue with ablation therapy
* Informed written consent to be included in the study
Exclusion Criteria
* pregnancy (and lack of exclusion of potential pregnancy)
* age below 18 years
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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Tamás Géczy
Cardiologist
Principal Investigators
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Tamas Szili-Torok, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Erasmus MC
Rotterdam, , Netherlands
Countries
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References
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Ullah W, Hunter RJ, Haldar S, McLean A, Dhinoja M, Sporton S, Earley MJ, Lorgat F, Wong T, Schilling RJ. Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: an international multicenter registry study. Pacing Clin Electrophysiol. 2014 Nov;37(11):1427-35. doi: 10.1111/pace.12501. Epub 2014 Sep 15.
Gerstenfeld EP. Contact force-sensing catheters: evolution or revolution in catheter ablation technology? Circ Arrhythm Electrophysiol. 2014 Feb;7(1):5-6. doi: 10.1161/CIRCEP.114.001424. No abstract available.
Shurrab M, Di Biase L, Briceno DF, Kaoutskaia A, Haj-Yahia S, Newman D, Lashevsky I, Nakagawa H, Crystal E. Impact of Contact Force Technology on Atrial Fibrillation Ablation: A Meta-Analysis. J Am Heart Assoc. 2015 Sep 21;4(9):e002476. doi: 10.1161/JAHA.115.002476.
Kautzner J, Neuzil P, Lambert H, Peichl P, Petru J, Cihak R, Skoda J, Wichterle D, Wissner E, Yulzari A, Kuck KH. EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace. 2015 Aug;17(8):1229-35. doi: 10.1093/europace/euv057. Epub 2015 Jun 3.
Kimura M, Sasaki S, Owada S, Horiuchi D, Sasaki K, Itoh T, Ishida Y, Kinjo T, Tomita H, Okumura K. Comparison of lesion formation between contact force-guided and non-guided circumferential pulmonary vein isolation: a prospective, randomized study. Heart Rhythm. 2014 Jun;11(6):984-91. doi: 10.1016/j.hrthm.2014.03.019. Epub 2014 Mar 18.
Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jais P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23. doi: 10.1016/j.hrthm.2011.08.021. Epub 2011 Aug 26.
Martinek M, Lemes C, Sigmund E, Derndorfer M, Aichinger J, Winter S, Nesser HJ, Purerfellner H. Clinical impact of an open-irrigated radiofrequency catheter with direct force measurement on atrial fibrillation ablation. Pacing Clin Electrophysiol. 2012 Nov;35(11):1312-8. doi: 10.1111/j.1540-8159.2012.03503.x. Epub 2012 Sep 4.
Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.
Geczy T, Ramdat Misier NL, Szili-Torok T. Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias (COBRA-PATH): a randomized controlled trial. Trials. 2020 Apr 9;21(1):321. doi: 10.1186/s13063-020-4219-1.
Other Identifiers
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NL62017.078.17
Identifier Type: -
Identifier Source: org_study_id
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