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Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways

Cardiac Arrhythmias Clinical Trial

Official title:
Safety and Efficacy of Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways: a Randomized Comparative Trial

Clinical Trial Summary

A randomized pilot study to evaluate safety and efficacy endpoints for treatment of para-hisian accessory pathways according to two different strategies of lesion formation. These patients will be divided into 2 groups with different strategies of treatment: group 1 treated with radiofrequency (RF) ablation, group 2 with cryotherapy (CRYO). The primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.

Clinical Trial Description

This is a randomized study on the safety and efficacy for percutaneous ablation of para-hisian accessory pathways according to two different modalities: radiofrequency (RF) or cryotherapy. Thirty patients with symptomatic or high-risk para-hisian accessory pathways, documented by previous electrophysiological study (EPS), referred to percutaneous catheter ablation, will be enrolled in this trial. After informed consent, these patients will be randomized in 2 groups with different current established strategies of invasive treatment. Group I: electrophysiological mapping and ablation with radiofrequency (RF) focal lesion formation. Group II: electrophysiological mapping and ablation with cryotherapy (CRYO) focal lesion formation. The primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04361006
Study type Interventional
Source University of Sao Paulo General Hospital
Contact
Status Completed
Phase N/A
Start date October 1, 2018
Completion date February 1, 2021
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