Comparision of PVC Ablation Techniques

Not Applicable

• Conditions: Premature Ventricular Contraction
• Interventions: Device: Radiofrequency Ablation Catheter; Device: Cryo Ablation catheter

• Registration Number: NCT03086902
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-22
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-06
• Study Start: 2018-12
• Primary Completion: 2020-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency Ablation	Radiofrequency Ablation Catheter	In this arm PVCs will be mapped and ablated with a Radiofrequency Ablation catheter
Cryo Ablation	Cryo Ablation catheter	PVCs will be mapped and ablated with a Cryo Ablation catheter

Primary Outcome Measures

Name	Time	Method
Comparison of successful catheter ablation between both methods.	During procedure and 1 month follow up	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

Name	Time	Method
Comparison of complications such as pericardial effusion/ tamponade, coronary artery damage and post procedure pericardial pain requiring medical management.	During Procedure	Any complication will be assessed clinically during procedure and managed as indicated.
Comparison of procedure and fluoroscopy time between both strategies	During Procedure	Time of procedure and fluoroscopy will be logged into CRF