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

NCT ID: NCT04215640

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2021-11-01

Brief Summary

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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

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Conditions

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Paroxysmal Supraventricular Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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MIFI group

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

Group Type EXPERIMENTAL

Microfidelity (MIFI) catheter

Intervention Type 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.

Control

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

Group Type ACTIVE_COMPARATOR

Conventional ablation catheter

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yong Seog Oh

OTHER

Sponsor Role lead

Responsible Party

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Yong Seog Oh

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yong-Seog Oh

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St Mary's Hospital

Seoul, Seo Ch-gu, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 35924472 (View on PubMed)

Other Identifiers

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XC19DEDI0078K

Identifier Type: -

Identifier Source: org_study_id