Comparision of PVC Ablation Techniques

NCT03086902 | Unknown FDA Device

• 1 other identifier: SMC-3991-17
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premature Ventricular Contraction

Keywords

Ablation; Cryo Energy; Radofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of complications such as pericardial effusion/ tamponade, coronary artery damage and post procedure pericardial pain requiring medical management.

  During Procedure

• Comparison of procedure and fluoroscopy time between both strategies

  During Procedure

Study Arms (2)

Cryo Ablation

EXPERIMENTAL

PVCs will be mapped and ablated with a Cryo Ablation catheter

Device: Cryo Ablation catheter

Radiofrequency Ablation

ACTIVE COMPARATOR

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

Device: Radiofrequency Ablation Catheter

Interventions

Radiofrequency Ablation Catheter DEVICE

Ablation of PVC with RF energy

Radiofrequency Ablation

Cryo Ablation catheter DEVICE

Ablation pf PVC with Cryo enerygy

Cryo Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for PVC ablation.
• Age ≥ 18 years on a date of consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Medtronic: collaborator

Related Publications (5)

• 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.

  PMID: 15828876 RESULT

• 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.

  PMID: 24293174 RESULT

• 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.

  PMID: 24096170 RESULT

• 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.

  PMID: 24931638 RESULT

• 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.

  PMID: 27069089 RESULT

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Eyal Nof, MD

CONTACT

+9725302604; eyal.nof@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Invasive Electrophysiology Service

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 22, 2017
• Study Start: December 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2021
• Last Updated: June 6, 2018

Record last verified: 2018-06