Safety and Efficacy of Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways: a Randomized Comparative Trial
Sponsor study identifier
Secondary identifiers
OTHER · WHO Universal Trial Number
interventional
30
1 country
1
Study Start
October 1, 2018
Actual (reported)Primary Completion
February 28, 2020
Actual (reported)Study Completion
February 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2018
Actual (reported)February 28, 2020
Actual (reported)April 19, 2020
Actual (reported)April 24, 2020
Actual (reported)February 1, 2021
Actual (reported)One-year recurrence rate
Recurrence rate of accessory pathway conduction, as assessed by follow-up Clinical recording and event monitoring external device (Holter/Looper).
One year
Immediate success rate
Time span between vein puncture (start of procedure) and sheath removal (end of procedure), comparing with baseline rhythm
Rate of atrioventricular block
up to 24 hours
Twenty patients will be allocated to this group, which will be treated using radiofrequency (RF) ablation technique.
Twenty patients will be allocated to this group, which will be treated using Cryotherapy (CRYO) ablation technique.
Will be evaluated if percutaneous radiofrequency catheter ablation is superior to cryotherapy as treatment modality of para-hisian accessory pathways.
Will be evaluated if percutaneous cryotherapy catheter ablation is superior to radiofrequency as treatment modality of para-hisian accessory pathways.
Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
São Paulo, São Paulo, 05403010, Brazil
Mauricio I Scanavacca, MD, PhD
Instituto do coração - HC/FMUSP
30 participants (actual enrollment reported by the registry).
First Submitted
April 19, 2020
First Posted
April 24, 2020
Study Start
October 1, 2018
Actual (reported)Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP)
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Primary Completion
February 28, 2020
Actual (reported)Study Completion
February 1, 2021
Actual (reported)Last Updated
May 19, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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