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

Primary Purpose

Paroxysmal Supraventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Microfidelity (MIFI) catheter
Conventional ablation catheter
Sponsored by
Yong Seog Oh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Supraventricular Tachycardia

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul St Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MIFI group

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
RF application number
Number of radiofrequency ablation attempt to successful ablation

Secondary Outcome Measures

Total ablation time (seconds)
Total time of radiofrequency energy delivery
Presence of either acute reconnection or reinduction
Acute accessory pathway reconnection or supraventricular tachycardia reinduction after ablation

Full Information

First Posted
December 30, 2019
Last Updated
November 1, 2021
Sponsor
Yong Seog Oh
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1. Study Identification

Unique Protocol Identification Number
NCT04215640
Brief Title
Radiofrequency Ablation of Paroxysmal Supraventricular Tachycardia Using a Novel Catheter Equipped With Mini Electrodes
Official Title
Radiofrequency Ablation of Paroxysmal Supraventricular Tachycardia Using a Novel Catheter Equipped With Mini Electrodes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Seog Oh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Supraventricular Tachycardia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIFI group
Arm Type
Experimental
Arm Description
Patients in the MIFI group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using microfidelity (MIFI) catheter.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in the control group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using conventional ablation catheter (Blazer II).
Intervention Type
Device
Intervention Name(s)
Microfidelity (MIFI) catheter
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional ablation catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
RF time (seconds) to successful ablation
Description
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
Time Frame
At the end of radiofrequency ablation procedure
Title
RF application number
Description
Number of radiofrequency ablation attempt to successful ablation
Time Frame
At the end of radiofrequency ablation procedure
Secondary Outcome Measure Information:
Title
Total ablation time (seconds)
Description
Total time of radiofrequency energy delivery
Time Frame
At the end of radiofrequency ablation procedure
Title
Presence of either acute reconnection or reinduction
Description
Acute accessory pathway reconnection or supraventricular tachycardia reinduction after ablation
Time Frame
At the end of radiofrequency ablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Seog Oh
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St Mary's Hospital
City
Seoul
State/Province
Seo Ch-gu
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD would be provided with an appropriate request from other investigators.
Citations:
PubMed Identifier
35924472
Citation
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.
Results Reference
derived

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

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