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

Safety and Efficacy of Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways: a Randomized Comparative Trial

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmias; Accessory Pathway; Wolf Parkinson White Syndrome
• Intervention / Treatment: Device: Radiofrequency (RF); Device: Cryotherapy (CRYO)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Italo BS Sousa, MD; Phone Number: +55112661-5341; Email: ibss_bruno@hotmail.com
• Study Contact Backup: Name: Mauricio I Scanavacca, MD, PhD; Phone Number: +55112661-5341; Email: mauricio.scanavacca@gmail.com

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403010
      • Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiofrequency (RF); Twenty patients will be allocated to this group, which will be treated using radiofrequency (RF) ablation technique.	Device: Radiofrequency (RF); Will be evaluated if percutaneous radiofrequency catheter ablation is superior to cryotherapy as treatment modality of para-hisian accessory pathways.
Active Comparator: Cryotherapy (CRYO); Twenty patients will be allocated to this group, which will be treated using Cryotherapy (CRYO) ablation technique.	Device: Cryotherapy (CRYO); Will be evaluated if percutaneous cryotherapy catheter ablation is superior to radiofrequency as treatment modality of para-hisian accessory pathways.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: InCor Heart Institute
• Investigators: Study Chair: Mauricio I Scanavacca, MD, PhD, Instituto do coração - HC/FMUSP

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: electrophysiology; cryoablation; radiofrequency; para-hisian; accessory pathway
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Arrhythmias, Cardiac; Pre-Excitation Syndromes; Wolff-Parkinson-White Syndrome; Accessory Atrioventricular Bundle
• Other Study ID Numbers: 4446/16/112; U1111-1250-5793 (Other Identifier: WHO Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes