Radiation Exposure Reduction in Supraventricular Tachycardia Ablation (NO-PARTY)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Radiofrequency catheter ablation (RFCA) is the mainstay of therapy for supraventricular tachyarrhythmias, providing cure in a high percentage of cases. Conventional ablation techniques require the use of fluoroscopy to place and navigate catheters in the heart, thus exposing patients to ionizing radiations with an additional risk of cancer. The feasibility and safety of a non-fluoroscopic RFCA of a wide range of supraventricular arrhythmias using the EnSite NavX mapping system have been recently reported. The NO-PARTY is a multicenter, randomized-controlled trial designed to test the hypothesis that supraventricular arrhythmias RFCA through the non-fluoroscopic EnSite NavX mapping system results in a clinically significant reduction of the exposure to ionizing radiations compared with conventional ablation techniques.

NO-PARTY trial will determine whether supraventricular tachyarrhythmia RFCA through a non-fluoroscopic EnSite NavX mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction of ionizing radiation exposure for both the patient and the operator.

Condition or disease	Intervention/treatment	Phase
Supraventricular Tachycardias	Procedure: Radiofrequency catheter ablation	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	210 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias
Study Start Date :	December 2009
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	March 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Conventional catheter ablation; Radiofrequency catheter ablation through fluoroscopic guidance	Procedure: Radiofrequency catheter ablation; Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.
Experimental: Non-fluoroscopic catheter ablation; Radiofrequency catheter ablation guided by the EnSite NavX (St.Jude Medical, St Paul, MN, USA) mapping-system	Procedure: Radiofrequency catheter ablation; Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.

Outcome Measures

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Primary Outcome Measures :

1. reduction of ionizing radiation exposure [ Time Frame: 1 day (radiation exposure will be evaluated at the end of procedure) ]
   the NO-PARTY trial was designed to compare a non-fluoroscopic catheter ablation guided by the EnSite NavXTM mapping system with conventional catheter ablation for supraventricular tachyarrhythmias in terms of ionizing radiation exposure for both the patient and the operator

Secondary Outcome Measures :

1. Cost-Effectiveness [ Time Frame: at 1 year ]
   The total reduction in fluoroscopy use with the non-fluoroscopic NavX mapping system approach is associated with a life-term ionizing radiation-exposure risk reduction, which will be estimated according to currently available ionizing radiation risk charts. Cost-effectiveness analysis will be performed taking into account such risk reduction, and the increased costs associated with the use of the nonfluoroscopic radiofrequency ablation approach.
2. Cost-Effectiveness [ Time Frame: at 2 years ]
   The total reduction in fluoroscopy use with the non-fluoroscopic NavX mapping system approach is associated with a life-term ionizing radiation-exposure risk reduction, which will be estimated according to currently available ionizing radiation risk charts. Cost-effectiveness analysis will be performed taking into account such risk reduction, and the increased costs associated with the use of the nonfluoroscopic radiofrequency ablation approach.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	14 Years to 50 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• male and female patients between 14 and 50 years of age who have received an indication to radiofrequency catheter ablation of supraventricular arrhythmias according to current guidelines.

Exclusion Criteria:

• atrial fibrillation or non isthmus-dependent atrial flutter
• pregnancy
• hematological contraindications to ionizing radiation exposure
• presence of complex congenital heart disease, and cardiac surgery within 1 month from enrollment

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Italy
Santa Maria della Misericordia - A.O. di Perugia
Perugia, PG, Italy, 06156
Arrhythmia Department, Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, Italy
CNR, Institute of Clinical Physiology, Fondazione G. Monasterio
Pisa, PI, Italy
Institute of Cardiology; Presidio Ospedaliero Santa Chiara
Trento, TN, Italy
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan
Milan, Italy, 20138
Catholic University of the Sacred Heart
Rome, Italy, 00198

Sponsors and Collaborators

Catholic University of the Sacred Heart

St. Jude Medical

CNR Institute of Clinical Physiology, Pisa, Italy

Investigators

Principal Investigator:	Michela Casella, MD, PhD	Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan, Milan, Italy

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Casella M, Dello Russo A, Pelargonio G, Bongiorni MG, Del Greco M, Piacenti M, Andreassi MG, Santangeli P, Bartoletti S, Moltrasio M, Fassini G, Marini M, Di Cori A, Di Biase L, Fiorentini C, Zecchi P, Natale A, Picano E, Tondo C. Rationale and design of the NO-PARTY trial: near-zero fluoroscopic exposure during catheter ablation of supraventricular arrhythmias in young patients. Cardiol Young. 2012 Oct;22(5):539-46. doi: 10.1017/S1047951112000042. Epub 2012 Feb 13.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Casella M, Dello Russo A, Pelargonio G, Del Greco M, Zingarini G, Piacenti M, Di Cori A, Casula V, Marini M, Pizzamiglio F, Zucchetti M, Riva S, Russo E, Narducci ML, Soldati E, Panchetti L, Startari U, Bencardino G, Perna F, Santangeli P, Di Biase L, Cichocki F, Fattore G, Bongiorni M, Picano E, Natale A, Tondo C. Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias: the NO-PARTY multicentre randomized trial. Europace. 2016 Oct;18(10):1565-1572. Epub 2015 Nov 10.

Responsible Party:	Michela Casella, MD, PhD, Cardiac Arrhythmia Research Centre, Department of Cardiovascular Medicine, Centro Cardiologico Monzino, University of Milan, Milan, Italy
ClinicalTrials.gov Identifier:	NCT01132274 History of Changes
Other Study ID Numbers:	UCSC210210
First Posted:	May 28, 2010
Last Update Posted:	April 15, 2013
Last Verified:	April 2013

Keywords provided by Catholic University of the Sacred Heart:

Supraventricular arrhythmia catheter ablation

Additional relevant MeSH terms:

Tachycardia; Tachycardia, Supraventricular; Arrhythmias, Cardiac	Heart Diseases; Cardiovascular Diseases; Pathologic Processes