Radiofrequency Ablation of Paroxysmal Supraventricular Tachycardia Using a Novel Catheter Equipped With Mini Electrodes

Paroxysmal supraventricular tachycardia is treated with radiofrequency ablation recently. This procedure is performed by ablating slow pathway or accessory pathway using radiofrequency ablation catheter. Recently developed mirofidelity (MIFI) catheter has mini-electrodes that can record local eletrogram with higher resolution. We aimed to investigate the efficacy of MIFI catheter in the ablation of paroxysmal supraventricular tachycardia compared to conventional radiofrequency ablation catheter. Enrolled patients undergo conventional electrophysiologic study. Patients with sustained supraventricular tachycardia during the study are randomized to either study group or control group. Radiofrequency ablation is performed using MIFI catheter in the study group, and conventional catheter (Blazer II) in the control group. The study endpoints are recorded immediately after ablation and there is no additional follow up or management after procedure.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Supraventricular Tachycardia
• Intervention / Treatment: Device: Microfidelity (MIFI) catheter; Device: Conventional ablation catheter

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seo Ch-gu
    • Seoul, Seo Ch-gu, Korea, Republic of, 137-701
      • Seoul St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are scheduled to undergo radiofrequency ablation for paroxysmal supraventricular tachycardia or WPW syndrome with atrial fibrillation
• Give written informed consent for the study

Exclusion Criteria:

• Unable to induce supraventricular tachycardia during electrophysiologic study.
• Cognitive impairment to understand study procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIFI group; Patients in the MIFI group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using microfidelity (MIFI) catheter.	Device: Microfidelity (MIFI) catheter; Patients are randomized into the MIFI group and control group. Radiofrequency ablation will target slow pathway for AVNRT or accessory pathway for AVRT. Microfidelity (MIFI) catheter equipped with mini-electrodes will be used for ablation in the MIFI group.
Active Comparator: Control; Patients in the control group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using conventional ablation catheter (Blazer II).	Device: Conventional ablation catheter; Patients are randomized into the MIFI group and control group. Radiofrequency ablation will target slow pathway for AVNRT or accessory pathway for AVRT. Blazer II radiofrequency ablation catheter will be used for ablation in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RF time (seconds) to successful ablation	For AVNRT, the time (seconds) from the beginning of radiofrequency ablation to the emergence of junctional rhythm For AVRT, the time (seconds) from the beginning of radiofrequency ablation to the accessory pathway block	At the end of radiofrequency ablation procedure
RF application number	Number of radiofrequency ablation attempt to successful ablation	At the end of radiofrequency ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total ablation time (seconds)	Total time of radiofrequency energy delivery	At the end of radiofrequency ablation procedure
Presence of either acute reconnection or reinduction	Acute accessory pathway reconnection or supraventricular tachycardia reinduction after ablation	At the end of radiofrequency ablation procedure

Collaborators and Investigators

• Sponsor: Yong Seog Oh
• Investigators: Principal Investigator: Yong-Seog Oh, Seoul st. mary's hospital

Publications and helpful links

General Publications

• Choi Y, Kim SH, Kim H, Park JW, Ha YW, Hwang Y, Kim JH, Jang SW, Oh YS. The advantage of the mini-electrode-equipped catheter for the radiofrequency ablation of paroxysmal supraventricular tachycardia. J Cardiovasc Electrophysiol. 2022 Oct;33(10):2164-2171. doi: 10.1111/jce.15639. Epub 2022 Aug 24.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular
• Other Study ID Numbers: XC19DEDI0078K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD would be provided with an appropriate request from other investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No