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 Details — Status: Completed

Administrative data

• NCT number: NCT04361006
• Other study ID #: 4446/16/112
• Secondary ID: U1111-1250-5793
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: May 2023
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2021
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Accessory Pathway
• Arrhythmias, Cardiac
• Cardiac Arrhythmias
• Pre-Excitation Syndromes
• Wolf Parkinson White Syndrome
• Wolff-Parkinson-White Syndrome

Intervention

Device:
• Radiofrequency (RF)
Will be evaluated if percutaneous radiofrequency catheter ablation is superior to cryotherapy as treatment modality of para-hisian accessory pathways.
• Cryotherapy (CRYO)
Will be evaluated if percutaneous cryotherapy catheter ablation is superior to radiofrequency as treatment modality of para-hisian accessory pathways.

Locations

Country	Name	City	State
Brazil	Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Immediate success rate	Mensuration of immediate success at the EP lab after ablation therapy is finished, defined by elimination of accessory pathway and/or noninducibility of arrhythmias at the end of procedure, as assessed by standard electrophysiological maneuvers.; If an evidence of accessory pathway conduction still remains at the end of procedure it will count as an unsuccessful case.; Does not take into account recurrences after the end of procedure, e.g. in the hospital ward before discharge.	Time span between vein puncture (start of procedure) and sheath removal (end of procedure), comparing with baseline rhythm
Secondary	Rate of atrioventricular block	Safety outcome of any permanent atrioventricular (AV) block that occurred immediately after ablation start or during hospital admission.	up to 24 hours