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

Paroxysmal Supraventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215640
• Other study ID #: XC19DEDI0078K
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Paroxysmal Supraventricular Tachycardia
• Tachycardia
• Tachycardia, Supraventricular
• Tachycardia, Ventricular

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul St Mary's Hospital	Seoul	Seo Ch-gu

Sponsors (1)

Lead Sponsor	Collaborator
Yong Seog Oh

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	RF application number	Number of radiofrequency ablation attempt to successful ablation	At the end of radiofrequency ablation procedure
Secondary	Total ablation time (seconds)	Total time of radiofrequency energy delivery	At the end of radiofrequency ablation procedure
Secondary	Presence of either acute reconnection or reinduction	Acute accessory pathway reconnection or supraventricular tachycardia reinduction after ablation	At the end of radiofrequency ablation procedure