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PVCCryo Ablation vs. Radiofrequency Catheter Ablation for Ventricular Premature Contractions

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What is being tested

Radiofrequency Ablation Catheter

+ Cryo Ablation catheter

Device
Who is being recruted

Cardiac Conduction System Disease+5

+ Arrhythmias, Cardiac

+ Cardiovascular Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2018
See protocol details

Summary

Principal SponsorSheba Medical Center
Study ContactEyal Nof, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2018

Actual date on which the first participant was enrolled.

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 TitleCryo Ablation vs. Radiofrequency Catheter Ablation for Ventricular Premature Contractions
NCT03086902
Principal SponsorSheba Medical Center
Study ContactEyal Nof, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

88 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiac Conduction System DiseaseArrhythmias, CardiacCardiovascular DiseasesCardiac Complexes, PrematureHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVentricular Premature Complexes

Criteria

2 inclusion criteria required to participate
Patients referred for PVC ablation.

Age ≥ 18 years on a date of consent.

5 exclusion criteria prevent from participating
Contraindications for ablation

Serious known concomitant disease with a life expectancy of < 1 year

Elderly patients >80 years of age

Pregnancy or nursing

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Experimental
PVCs will be mapped and ablated with a Cryo Ablation catheter

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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