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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361006
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
InCor Heart Institute
Medtronic
Information provided by (Responsible Party):
Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital

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 six months of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.


Condition or disease Intervention/treatment Phase
Cardiac Arrhythmias Accessory Pathway Wolf Parkinson White Syndrome Device: Radiofrequency (RF) Device: Cryotherapy (CRYO) Not Applicable

Detailed Description:

This is a randomized pilot study on the safety and efficacy for percutaneous ablation of para-hisian accessory pathways according to two different modalities: radiofrequency (RF) of cryotherapy.

Forty 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 six months of follow-up. Secondary endpoints will be immediate success and rate of permanent atrioventricular (AV) block.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Cryotherapy Versus Radiofrequency Ablation for Treatment of Para-hisian Accessory Pathways: a Randomized Comparative Trial
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Six-month recurrence rate [ Time Frame: Six months ]
    Recurrence rate of accessory pathway conduction, as assessed by follow-up Clinical recording and event monitoring external device (Holter/Looper).


Secondary Outcome Measures :
  1. Immediate success rate [ Time Frame: Time span between vein puncture (start of procedure) and sheath removal (end of procedure), comparing with baseline rhythm ]

    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.


  2. Rate of atrioventricular block [ Time Frame: up to 24 hours ]
    Safety outcome of any permanent atrioventricular (AV) block that occurred immediately after ablation start or during hospital admission.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361006


Contacts
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Contact: Italo BS Sousa, MD +55112661-5341 ibss_bruno@hotmail.com
Contact: Mauricio I Scanavacca, MD, PhD +55112661-5341 mauricio.scanavacca@gmail.com

Locations
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Brazil
Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP Recruiting
São Paulo, SP, Brazil, 05403010
Contact: Italo BS Sousa, MD    +5511952017705    ibss_bruno@hotmail.com   
Contact: Mauricio I Scanavacca, MD, PhD    +55112661-5341    mauricio.scanavacca@gmail.com   
Principal Investigator: Mauricio I Scanavacca, MD, PhD         
Sub-Investigator: Sissy L de Melo, MD, PhD         
Sub-Investigator: Muhieddine O Chokr, MD         
Sub-Investigator: Cristiano F Pisani, MD, PhD         
Sub-Investigator: Carina A Hardy, MD         
Sub-Investigator: Italo BS Sousa, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
InCor Heart Institute
Medtronic
Investigators
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Study Chair: Mauricio I Scanavacca, MD, PhD Instituto do coração - HC/FMUSP
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Responsible Party: Mauricio Ibrahim Scanavacca, Arrhythmia Unit Director - Heart Institute (InCor), MD, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04361006    
Other Study ID Numbers: 4446/16/112
U1111-1250-5793 ( Other Identifier: WHO Universal Trial Number )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Mauricio Ibrahim Scanavacca, University of Sao Paulo General Hospital:
para-hisian
radiofrequency
cryoablation
accessory pathway
electrophysiology
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Pre-Excitation Syndromes
Wolff-Parkinson-White Syndrome
Accessory Atrioventricular Bundle
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities