Status:
COMPLETED
Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
InCor Heart Institute
Conditions:
Cardiac Arrhythmias
Accessory Pathway
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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 di...
Detailed 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 pat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04361006
Start Date
October 1 2018
End Date
February 1 2021
Last Update
May 19 2023
Active Locations (1)
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1
Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
São Paulo, São Paulo, Brazil, 05403010