Comparision of PVC Ablation Techniques

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cryo Ablation vs. Radiofrequency Catheter Ablation for Ventricular Premature Contractions

Conditions
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Premature Ventricular Contraction

Intervention / Treatment
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* Device: Radiofrequency Ablation Catheter
* Device: Cryo Ablation catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryo Ablation<br>PVCs will be mapped and ablated with a Cryo Ablation catheter | Device: Cryo Ablation catheter<br>* Ablation pf PVC with Cryo enerygy<br>|
| Active Comparator: Radiofrequency Ablation<br>In this arm PVCs will be mapped and ablated with a Radiofrequency Ablation catheter | Device: Radiofrequency Ablation Catheter<br>* Ablation of PVC with RF energy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During procedure and 1 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During Procedure | 
| Comparison of procedure and fluoroscopy time between both strategies | Time of procedure and fluoroscopy will be logged into CRF | During Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ablation; Cryo Energy; Radofrequency Ablation