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

Yong Seog Oh

Status: Completed

Conditions: Paroxysmal Supraventricular Tachycardia

Treatments: Device: Conventional ablation catheter; Device: Microfidelity (MIFI) catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT04215640

XC19DEDI0078K

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

MIFI group

Experimental group

Description:

Patients in the MIFI group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using microfidelity (MIFI) catheter.

Treatment:

Device: Microfidelity (MIFI) catheter

Control

Active Comparator group

Description:

Patients in the control group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using conventional ablation catheter (Blazer II).

Treatment:

Device: Conventional ablation catheter