Comparision of PVC Ablation Techniques

Premature Ventricular Contraction Clinical Trial

— PVC  

Official title:

Cryo Ablation vs. Radiofrequency Catheter Ablation for Ventricular Premature Contractions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03086902
• Other study ID #: SMC-3991-17
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2018
• Est. completion date: July 2021

Study information

• Verified date: June 2018
• Source: Sheba Medical Center
• Contact: Eyal Nof, MD
• Phone: +9725302604
• Email: eyal.nof[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: July 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ventricular Contraction
• Ventricular Premature Complexes

Intervention

Device:
• Radiofrequency Ablation Catheter
Ablation of PVC with RF energy
• Cryo Ablation catheter
Ablation pf PVC with Cryo enerygy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Medtronic

References & Publications (5)

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 ca — View Citation

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. — View Citation

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. Ep — View Citation

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 Arrhythmia — View Citation

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. Revie — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of successful catheter ablation between both methods.	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	Comparison of complications such as pericardial effusion/ tamponade, coronary artery damage and post procedure pericardial pain requiring medical management.	Any complication will be assessed clinically during procedure and managed as indicated.	During Procedure
Secondary	Comparison of procedure and fluoroscopy time between both strategies	Time of procedure and fluoroscopy will be logged into CRF	During Procedure