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

NCT04215640 | Completed

• 1 other identifier: XC19DEDI0078K
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Supraventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Total ablation time (seconds)

  At the end of radiofrequency ablation procedure

• Presence of either acute reconnection or reinduction

  At the end of radiofrequency ablation procedure

Study Arms (2)

MIFI group

EXPERIMENTAL

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

Device: Microfidelity (MIFI) catheter

Control

ACTIVE COMPARATOR

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

Device: Conventional ablation catheter

Interventions

Microfidelity (MIFI) catheter DEVICE

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.

MIFI group

Conventional ablation catheter DEVICE

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.

Control

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yong Seog Oh: lead

Study Sites (1)

Seoul St Mary's Hospital

Seoul, Seo Ch-gu, 137-701, South Korea

Location

Related Publications (1)

• 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.

  PMID: 35924472 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Catheters

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Yong-Seog Oh

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: January 13, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)