Comparision of PVC Ablation Techniques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2021-07-31

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.

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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.

Conditions

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Premature Ventricular Contraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cryo Ablation

PVCs will be mapped and ablated with a Cryo Ablation catheter

Group Type EXPERIMENTAL

Cryo Ablation catheter

Intervention Type DEVICE

Ablation pf PVC with Cryo enerygy

Radiofrequency Ablation

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

Group Type ACTIVE_COMPARATOR

Radiofrequency Ablation Catheter

Intervention Type DEVICE

Ablation of PVC with RF energy

Interventions

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Radiofrequency Ablation Catheter

Ablation of PVC with RF energy

Intervention Type DEVICE

Cryo Ablation catheter

Ablation pf PVC with Cryo enerygy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No