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Rationale and design of the NO-PARTY trial: near-zero fluoroscopic exposure during catheter ablation of supraventricular arrhythmias in young patients

Published online by Cambridge University Press:  13 February 2012

Michela Casella*
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy
Antonio Dello Russo
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy
Gemma Pelargonio
Affiliation:
Department of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy
Maria Grazia Bongiorni
Affiliation:
Department of Cardiovascular Disease 2, Santa Chiara Hospital, Hospital University of Pisa, Italy
Maurizio Del Greco
Affiliation:
Department of Cardiology, Santa Chiara Hospital, Trento, Italy
Marcello Piacenti
Affiliation:
CNR, Institute of Clinical Physiology, Fondazione G. Monasterio, Pisa, Italy
Maria Grazia Andreassi
Affiliation:
CNR, Institute of Clinical Physiology, Fondazione G. Monasterio, Pisa, Italy
Pasquale Santangeli
Affiliation:
Department of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy
Stefano Bartoletti
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy Department of Cardiovascular Sciences, University of Milan, Milan, Italy
Massimo Moltrasio
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy
Gaetano Fassini
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy
Massimiliano Marini
Affiliation:
Department of Cardiology, Santa Chiara Hospital, Trento, Italy
Andrea Di Cori
Affiliation:
Department of Cardiovascular Disease 2, Santa Chiara Hospital, Hospital University of Pisa, Italy
Luigi Di Biase
Affiliation:
Texas Cardiac Arrhythmia Institute, St. Davis Medical Center, Austin, Texas, United States of America
Cesare Fiorentini
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy Department of Cardiovascular Sciences, University of Milan, Milan, Italy
Paolo Zecchi
Affiliation:
Department of Cardiovascular Medicine, Catholic University of the Sacred Heart, Rome, Italy
Andrea Natale
Affiliation:
Texas Cardiac Arrhythmia Institute, St. Davis Medical Center, Austin, Texas, United States of America
Eugenio Picano
Affiliation:
CNR, Institute of Clinical Physiology, Fondazione G. Monasterio, Pisa, Italy
Claudio Tondo
Affiliation:
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy
*
Correspondence to: Dr M. Casella, MD, PhD, Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Via Parea 4, 20138 Milan, Italy. Tel: +39 02 58002340; Fax: +39 02 58002398; E-mail: [email protected]

Abstract

Introduction

Radiofrequency catheter ablation is the mainstay of therapy for supraventricular tachyarrhythmias. Conventional radiofrequency catheter ablation requires the use of fluoroscopy, thus exposing patients to ionising radiation. The feasibility and safety of non-fluoroscopic radiofrequency catheter ablation has been recently reported in a wide range of supraventricular tachyarrhythmias using the EnSite NavX™ mapping system. The NO-PARTY is a multi-centre, randomised controlled trial designed to test the hypothesis that catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system results in a clinically significant reduction in exposure to ionising radiation compared with conventional catheter ablation.

Methods

The study will randomise 210 patients undergoing catheter ablation of supraventricular tachyarrhythmias to either a conventional ablation technique or one guided by the EnSite NavX™ mapping system. The primary end-point is the reduction of the radiation dose to the patient. Secondary end-points include procedural success, reduction of the radiation dose to the operator, and a cost-effectiveness analysis. In a subgroup of patients, we will also evaluate the radiobiological effectiveness of dose reduction by assessing acute chromosomal DNA damage in peripheral blood lymphocytes.

Conclusions

NO-PARTY will determine whether radiofrequency catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction in ionising radiation exposure for both patient and operator.

Type
Original Article
Copyright
Copyright © Cambridge University Press 2012

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