CompletedNot Applicable

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

Brazil30 participantsStarted 2018-10-01

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with para-hisian accessory pathways, diagnosed by electrophysiological study (EPS), with indication of invasive treatment according to current guidelines. Patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form. Exclusion Criteria: * Previous cryotherapy ablation; * Previous extensive radiofrequency ablation (including aortic cusp mapping); * Age below twelve years; * Severe coagulation disorder; * Pregnancy; * Refusal to participate in the study.

What they're measuring

One-year recurrence rate

Timeframe: One year

Trial details

NCT IDNCT04361006

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-28

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