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Safety and Efficacy of Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways: a Randomized Comparative Trial
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.
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.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
São Paulo, São Paulo, Brazil
Start Date
October 1, 2018
Primary Completion Date
February 28, 2020
Completion Date
February 1, 2021
Last Updated
May 19, 2023
30
ACTUAL participants
Radiofrequency (RF)
DEVICE
Cryotherapy (CRYO)
DEVICE
Lead Sponsor
University of Sao Paulo General Hospital
Collaborators
NCT06854081
NCT07020910
NCT06898307
Data Source & Attribution
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