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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Arrhythmias Accessory Pathway Wolf Parkinson White Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency (RF)

Twenty patients will be allocated to this group, which will be treated using radiofrequency (RF) ablation technique.

Group Type ACTIVE_COMPARATOR

Radiofrequency (RF)

Intervention Type DEVICE

Will be evaluated if percutaneous radiofrequency catheter ablation is superior to cryotherapy as treatment modality of para-hisian accessory pathways.

Cryotherapy (CRYO)

Twenty patients will be allocated to this group, which will be treated using Cryotherapy (CRYO) ablation technique.

Group Type ACTIVE_COMPARATOR

Cryotherapy (CRYO)

Intervention Type DEVICE

Will be evaluated if percutaneous cryotherapy catheter ablation is superior to radiofrequency as treatment modality of para-hisian accessory pathways.

Interventions

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Radiofrequency (RF)

Will be evaluated if percutaneous radiofrequency catheter ablation is superior to cryotherapy as treatment modality of para-hisian accessory pathways.

Intervention Type DEVICE

Cryotherapy (CRYO)

Will be evaluated if percutaneous cryotherapy catheter ablation is superior to radiofrequency as treatment modality of para-hisian accessory pathways.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No