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
About this trial
This is an interventional treatment trial for Premature Ventricular Contraction focused on measuring Ablation; Cryo Energy; Radofrequency Ablation
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
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
NCT ID
NCT03086902
First Posted
March 16, 2017
Last Updated
June 5, 2018
Sponsor
Sheba Medical Center
Collaborators
Medtronic
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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Comparision of PVC Ablation Techniques
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