Comparision of PVC Ablation Techniques

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03086902

Collaborator

Medtronic (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Ventricular Contraction	Device: Radiofrequency Ablation Catheter Device: Cryo Ablation catheter	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

Cryo Ablation vs. Radiofrequency Catheter Ablation for Ventricular Premature Contractions

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cryo Ablation PVCs will be mapped and ablated with a Cryo Ablation catheter	Device: Cryo Ablation catheter Ablation pf PVC with Cryo enerygy
Active Comparator: Radiofrequency Ablation In this arm PVCs will be mapped and ablated with a Radiofrequency Ablation catheter	Device: Radiofrequency Ablation Catheter Ablation of PVC with RF energy

Arm

Intervention/Treatment

Experimental: Cryo Ablation

PVCs will be mapped and ablated with a Cryo Ablation catheter

Device: Cryo Ablation catheter

Ablation pf PVC with Cryo enerygy

Active Comparator: Radiofrequency Ablation

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

Device: Radiofrequency Ablation Catheter

Ablation of PVC with RF energy

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sheba Medical Center
Medtronic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Eyal Nof, Director of Invasive Electrophysiology Service, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT03086902

Other Study ID Numbers:

SMC-3991-17

First Posted:

Mar 22, 2017

Last Update Posted:

Jun 6, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Dr. Eyal Nof, Director of Invasive Electrophysiology Service, Sheba Medical Center

Ablation; Cryo Energy; Radofrequency Ablation

Additional relevant MeSH terms:

Premature Birth

Ventricular Premature Complexes

Study Results

No Results Posted as of Jun 6, 2018