Clinical trial NCT04361006: Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways
Official title: Safety and Efficacy of Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways: a Randomized Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmias
Accessory Pathway
Wolf Parkinson White Syndrome
Keywords: para-hisian
radiofrequency
cryoablation
accessory pathway
electrophysiology
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
First posted: 2020-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: One-year recurrence rate
timeFrame: One year
Secondary outcomes:
measure: Immediate success rate
timeFrame: Time span between vein puncture (start of procedure) and sheath removal (end of procedure), comparing with baseline rhythm
measure: Rate of atrioventricular block
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
state: SP
Study officials:
affiliation: Instituto do coração - HC/FMUSP
name: Mauricio I Scanavacca, MD, PhD
role: STUDY_CHAIR
References: