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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 1, 2021

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: MIFI group
    • Patients in the MIFI group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using microfidelity (MIFI) catheter.
  • Active Comparator: Control
    • Patients in the control group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using conventional ablation catheter (Blazer II).

Clinical Trial Outcome Measures

Primary Measures

  • RF time (seconds) to successful ablation
    • Time Frame: At the end of radiofrequency ablation procedure
    • 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
  • RF application number
    • Time Frame: At the end of radiofrequency ablation procedure
    • Number of radiofrequency ablation attempt to successful ablation

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yong Seog Oh
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Yong Seog Oh, professor – Seoul St. Mary’s Hospital
  • Overall Official(s)
    • Yong-Seog Oh, Principal Investigator, Seoul St. Mary’s Hospital

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