- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03086902
Comparision of PVC Ablation Techniques (PVC)
Cryo Ablation vs. Radiofrequency Catheter Ablation for Ventricular Premature Contractions
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eyal Nof, MD
- Phone Number: +9725302604
- Email: eyal.nof@sheba.health.gov.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryo Ablation
PVCs will be mapped and ablated with a 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
|
Ablation of PVC with RF energy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of successful catheter ablation between both methods.
Time Frame: 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.
|
During procedure and 1 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of complications such as pericardial effusion/ tamponade, coronary artery damage and post procedure pericardial pain requiring medical management.
Time Frame: During Procedure
|
Any complication will be assessed clinically during procedure and managed as indicated.
|
During Procedure
|
Comparison of procedure and fluoroscopy time between both strategies
Time Frame: During Procedure
|
Time of procedure and fluoroscopy will be logged into CRF
|
During Procedure
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Kurzidim K, Schneider HJ, Kuniss M, Sperzel J, Greiss H, Berkowitsch A, Pitschner HF. Cryocatheter ablation of right ventricular outflow tract tachycardia. J Cardiovasc Electrophysiol. 2005 Apr;16(4):366-9. doi: 10.1046/j.1540-8167.2005.40571.x.
- Santangeli P, Proietti R, Di Biase L, Bai R, Natale A. Cryoablation versus radiofrequency ablation of atrioventricular nodal reentrant tachycardia. J Interv Card Electrophysiol. 2014 Mar;39(2):111-9. doi: 10.1007/s10840-013-9842-2. Epub 2013 Nov 29.
- McDonnell K, Rhee E, Srivathsan K, Su W. Novel utility of cryoablation for ventricular arrhythmias arising from the left aortic cusp near the left main coronary artery: a case series. Heart Rhythm. 2014 Jan;11(1):34-8. doi: 10.1016/j.hrthm.2013.10.008. Epub 2013 Oct 3.
- Chung FP, Chong E, Lin YJ, Chang SL, Lo LW, Hu YF, Tuan TC, Chao TF, Liao JN, Huang YC, Chi PC, Chan CS, Chen YY, Huang HK, Chen SA. Different characteristics and electrophysiological properties between early and late recurrences after acute successful catheter ablation of idiopathic right ventricular outflow tract arrhythmias during long-term follow-up. Heart Rhythm. 2014 Oct;11(10):1760-9. doi: 10.1016/j.hrthm.2014.06.011. Epub 2014 Jun 12.
- Rivera S, Ricapito Mde L, Tomas L, Parodi J, Bardera Molina G, Banega R, Bueti P, Orosco A, Reinoso M, Caro M, Belardi D, Albina G, Giniger A, Scazzuso F. Results of Cryoenergy and Radiofrequency-Based Catheter Ablation for Treating Ventricular Arrhythmias Arising From the Papillary Muscles of the Left Ventricle, Guided by Intracardiac Echocardiography and Image Integration. Circ Arrhythm Electrophysiol. 2016 Apr;9(4):e003874. doi: 10.1161/CIRCEP.115.003874.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC-3991-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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