Comparision of PVC Ablation Techniques

Sheba Medical Center

Status: Unknown

Conditions: Premature Ventricular Contraction

Treatments: Device: Radiofrequency Ablation Catheter; Device: Cryo Ablation catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03086902

SMC-3991-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Cryo Ablation

Experimental group

Description:

PVCs will be mapped and ablated with a Cryo Ablation catheter

Treatment:

Device: Cryo Ablation catheter

Radiofrequency Ablation

Active Comparator group

Description:

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

Treatment:

Device: Radiofrequency Ablation Catheter