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

Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias

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.

Study Overview

• Status: Completed
• Conditions: Supraventricular Tachycardias
• Intervention / Treatment: Procedure: Radiofrequency catheter ablation; Procedure: Radiofrequency catheter ablation

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.; Procedure: Radiofrequency catheter ablation; Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.
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; Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.; Procedure: Radiofrequency catheter ablation; Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reduction of ionizing radiation exposure	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	1 day (radiation exposure will be evaluated at the end of procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-Effectiveness	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.	at 1 year
Cost-Effectiveness	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.	at 2 years

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Collaborators: Abbott Medical Devices; 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

Publications and helpful links

General 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.
• 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. doi: 10.1093/europace/euv344. Epub 2015 Nov 10.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: March 4, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (ESTIMATE): May 28, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 15, 2013
• Last Update Submitted That Met QC Criteria: April 12, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Supraventricular arrhythmia catheter ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Supraventricular
• Other Study ID Numbers: UCSC210210