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

Not Applicable

Completed

• Conditions: Paroxysmal Supraventricular Tachycardia
• Interventions: Device: Microfidelity (MIFI) catheter; Device: Conventional ablation catheter

• Registration Number: NCT04215640
• Lead Sponsor: Yong Seog Oh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Study Start: 2020-01-13
• Status Verified: 2021-11
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIFI group	Microfidelity (MIFI) catheter	Patients in the MIFI group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using microfidelity (MIFI) catheter.
Control	Conventional ablation catheter	Patients in the control group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using conventional ablation catheter (Blazer II).

Primary Outcome Measures

Name	Time	Method
RF time (seconds) to successful ablation	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	At the end of radiofrequency ablation procedure	Number of radiofrequency ablation attempt to successful ablation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul St Mary's Hospital; 🇰🇷 Seoul, Seo Ch-gu, Korea, Republic of