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

NCT04361006 | Completed FDA Device

• 2 other identifiers: 4446/16/112U1111-1250-5793
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrhythmias; Accessory Pathway; Wolf Parkinson White Syndrome

Keywords

para-hisian; radiofrequency; cryoablation; accessory pathway; electrophysiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Radiofrequency (RF)

ACTIVE COMPARATOR

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

Device: Radiofrequency (RF)

Cryotherapy (CRYO)

ACTIVE COMPARATOR

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

Device: Cryotherapy (CRYO)

Interventions

Radiofrequency (RF) DEVICE

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

Radiofrequency (RF)

Cryotherapy (CRYO) DEVICE

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

Cryotherapy (CRYO)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• InCor Heart Institute: collaborator

Study Sites (1)

Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP

São Paulo, São Paulo, 05403010, Brazil

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Pre-Excitation Syndromes; Wolff-Parkinson-White Syndrome

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mauricio I Scanavacca, MD, PhD

  Instituto do coração - HC/FMUSP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arrhythmia Unit Director - Heart Institute (InCor), MD, PhD

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 24, 2020
• Study Start: October 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 1, 2021
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)