Paroxysmal Supraventricular Tachycardia
Conditions
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.
Interventions
DEVICEMicrofidelity (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.
DEVICEConventional 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.
Sponsors
Yong Seog Oh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RF time (seconds) to successful ablation | At the end of radiofrequency ablation procedure | 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 | At the end of radiofrequency ablation procedure | Number of radiofrequency ablation attempt to successful ablation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total ablation time (seconds) | At the end of radiofrequency ablation procedure | Total time of radiofrequency energy delivery |
| Presence of either acute reconnection or reinduction | At the end of radiofrequency ablation procedure | Acute accessory pathway reconnection or supraventricular tachycardia reinduction after ablation |
Countries
South Korea
Outcome results
None listed