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Comparision of PVC Ablation Techniques (PVC)

Primary Purpose

Premature Ventricular Contraction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radiofrequency Ablation Catheter
Cryo Ablation catheter
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ventricular Contraction focused on measuring Ablation; Cryo Energy; Radofrequency Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Patients referred for PVC ablation.
  2. Age ≥ 18 years on a date of consent.

Exclusion criteria:

  1. Contraindications for ablation
  2. Serious known concomitant disease with a life expectancy of < 1 year
  3. Elderly patients >80 years of age
  4. Pregnancy or nursing
  5. Unwilling or unable to give informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cryo Ablation

    Radiofrequency Ablation

    Arm Description

    PVCs will be mapped and ablated with a Cryo Ablation catheter

    In this arm PVCs will be mapped and ablated with a Radiofrequency Ablation catheter

    Outcomes

    Primary Outcome Measures

    Comparison of successful catheter ablation between both methods.
    Successful ablation will be defined as absence of clinical VA or > 50% reduction in arrhythmia burden on Holter in the absence of anti-arrhythmic medication.

    Secondary Outcome Measures

    Comparison of complications such as pericardial effusion/ tamponade, coronary artery damage and post procedure pericardial pain requiring medical management.
    Any complication will be assessed clinically during procedure and managed as indicated.
    Comparison of procedure and fluoroscopy time between both strategies
    Time of procedure and fluoroscopy will be logged into CRF

    Full Information

    First Posted
    March 16, 2017
    Last Updated
    June 5, 2018
    Sponsor
    Sheba Medical Center
    Collaborators
    Medtronic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03086902
    Brief Title
    Comparision of PVC Ablation Techniques
    Acronym
    PVC
    Official Title
    Cryo Ablation vs. Radiofrequency Catheter Ablation for Ventricular Premature Contractions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2018 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sheba Medical Center
    Collaborators
    Medtronic

    4. Oversight

    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.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Several reports have shown the utility of PVC ablation with cryo catheters. The aim of this study is to compare the outcomes and safety of Cryo vs. RF for PVCs.
    Detailed Description
    Background: Radiofrequency (RF) catheter ablation (CA) is an effective therapeutic strategy in eliminating refractory idiopathic ventricular outflow tract (OT) ventricular arrhythmias (VA). However, early and late recurrences occur commonly. RFCA has also been reported to be associated with collateral damage and pain. The use of Cryo ablation as a safer alternative energy source been previously described. In several reports Cryo was reported to successfully treat VA originating from the OT in the absence of ablation related pain and collateral damage to adjacent structures such as the coronaries. When comparing outcomes and complications of catheter ablation of VA from the papillary muscles of the left ventricle with either Cryo or RF, Cryo was found to be associated with significantly higher success rates and lower recurrence rates than RFCA. Aim: To compare the outcomes and safety of Cryo vs. RF for PVCs. Methods: Patients with PVC VA will be randomized in a 1:1 fashion to RFCA or Cryo ablation. All procedures will be done using a 3-dimensional mapping system (EnSite™ NavX™ system, St. Jude Medical). Ablation will be performed at sites with earliest activation or at least pacemap exhibiting QRS morphology match of >11/12. Endpoint of procedure will be elimination and non inducibility of the clinical VA. All patients will undergo continuous monitoring for at least 12 hours post procedure and 12 lead Holter and exercise testing 1 month post procedure. Successful ablation will be defined as absence of clinical VA or > 50% reduction in arrhythmia burden on Holter in the absence of anti-arrhythmic medications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ventricular Contraction
    Keywords
    Ablation; Cryo Energy; Radofrequency Ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group sample sizes of 44 in Group 1 and 44 in Group 2 achieve 80% power to detect a difference between the group proportions of -0.2000. The proportion in Group 1 (the treatment group) is assumed to be 0.2500 under the null hypothesis and 0.0500 under the alternative hypothesis. The proportion in Group 2 (the control group) is 0.2500. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500. The significance level actually achieved by this design is 0.0531.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cryo Ablation
    Arm Type
    Experimental
    Arm Description
    PVCs will be mapped and ablated with a Cryo Ablation catheter
    Arm Title
    Radiofrequency Ablation
    Arm Type
    Active Comparator
    Arm Description
    In this arm PVCs will be mapped and ablated with a Radiofrequency Ablation catheter
    Intervention Type
    Device
    Intervention Name(s)
    Radiofrequency Ablation Catheter
    Intervention Description
    Ablation of PVC with RF energy
    Intervention Type
    Device
    Intervention Name(s)
    Cryo Ablation catheter
    Intervention Description
    Ablation pf PVC with Cryo enerygy
    Primary Outcome Measure Information:
    Title
    Comparison of successful catheter ablation between both methods.
    Description
    Successful ablation will be defined as absence of clinical VA or > 50% reduction in arrhythmia burden on Holter in the absence of anti-arrhythmic medication.
    Time Frame
    During procedure and 1 month follow up
    Secondary Outcome Measure Information:
    Title
    Comparison of complications such as pericardial effusion/ tamponade, coronary artery damage and post procedure pericardial pain requiring medical management.
    Description
    Any complication will be assessed clinically during procedure and managed as indicated.
    Time Frame
    During Procedure
    Title
    Comparison of procedure and fluoroscopy time between both strategies
    Description
    Time of procedure and fluoroscopy will be logged into CRF
    Time Frame
    During Procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Patients referred for PVC ablation. Age ≥ 18 years on a date of consent. Exclusion criteria: Contraindications for ablation Serious known concomitant disease with a life expectancy of < 1 year Elderly patients >80 years of age Pregnancy or nursing Unwilling or unable to give informed consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eyal Nof, MD
    Phone
    +9725302604
    Email
    eyal.nof@sheba.health.gov.il

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    All data will be kept at SMC and will be available
    Citations:
    PubMed Identifier
    15828876
    Citation
    Kurzidim K, Schneider HJ, Kuniss M, Sperzel J, Greiss H, Berkowitsch A, Pitschner HF. Cryocatheter ablation of right ventricular outflow tract tachycardia. J Cardiovasc Electrophysiol. 2005 Apr;16(4):366-9. doi: 10.1046/j.1540-8167.2005.40571.x.
    Results Reference
    result
    PubMed Identifier
    24293174
    Citation
    Santangeli P, Proietti R, Di Biase L, Bai R, Natale A. Cryoablation versus radiofrequency ablation of atrioventricular nodal reentrant tachycardia. J Interv Card Electrophysiol. 2014 Mar;39(2):111-9. doi: 10.1007/s10840-013-9842-2. Epub 2013 Nov 29.
    Results Reference
    result
    PubMed Identifier
    24096170
    Citation
    McDonnell K, Rhee E, Srivathsan K, Su W. Novel utility of cryoablation for ventricular arrhythmias arising from the left aortic cusp near the left main coronary artery: a case series. Heart Rhythm. 2014 Jan;11(1):34-8. doi: 10.1016/j.hrthm.2013.10.008. Epub 2013 Oct 3.
    Results Reference
    result
    PubMed Identifier
    24931638
    Citation
    Chung FP, Chong E, Lin YJ, Chang SL, Lo LW, Hu YF, Tuan TC, Chao TF, Liao JN, Huang YC, Chi PC, Chan CS, Chen YY, Huang HK, Chen SA. Different characteristics and electrophysiological properties between early and late recurrences after acute successful catheter ablation of idiopathic right ventricular outflow tract arrhythmias during long-term follow-up. Heart Rhythm. 2014 Oct;11(10):1760-9. doi: 10.1016/j.hrthm.2014.06.011. Epub 2014 Jun 12.
    Results Reference
    result
    PubMed Identifier
    27069089
    Citation
    Rivera S, Ricapito Mde L, Tomas L, Parodi J, Bardera Molina G, Banega R, Bueti P, Orosco A, Reinoso M, Caro M, Belardi D, Albina G, Giniger A, Scazzuso F. Results of Cryoenergy and Radiofrequency-Based Catheter Ablation for Treating Ventricular Arrhythmias Arising From the Papillary Muscles of the Left Ventricle, Guided by Intracardiac Echocardiography and Image Integration. Circ Arrhythm Electrophysiol. 2016 Apr;9(4):e003874. doi: 10.1161/CIRCEP.115.003874.
    Results Reference
    result

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