Casella Michela, Dello Russo Antonio, Pelargonio Gemma, Bongiorni Maria Grazia, Del Greco Maurizio, Piacenti Marcello, Andreassi Maria Grazia, Santangeli Pasquale, Bartoletti Stefano, Moltrasio Massimo, Fassini Gaetano, Marini Massimiliano, Di Cori Andrea, Di Biase Luigi, Fiorentini Cesare, Zecchi Paolo, Natale Andrea, Picano Eugenio, Tondo Claudio
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy.
Cardiol Young. 2012 Oct;22(5):539-46. doi: 10.1017/S1047951112000042. Epub 2012 Feb 13.
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.
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.
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.
射频导管消融术是治疗室上性快速心律失常的主要方法。传统的射频导管消融术需要使用荧光透视，从而使患者暴露于电离辐射中。最近有报道称，使用EnSite NavX™标测系统，非荧光透视射频导管消融术在多种室上性快速心律失常中具有可行性和安全性。NO-PARTY是一项多中心随机对照试验，旨在验证以下假设：与传统导管消融术相比，使用EnSite NavX™标测系统引导的室上性快速心律失常导管消融术能显著减少患者对电离辐射的暴露。
该研究将把210名接受室上性快速心律失常导管消融术的患者随机分为传统消融技术组或由EnSite NavX™标测系统引导的消融技术组。主要终点是患者辐射剂量的减少。次要终点包括手术成功率、术者辐射剂量的减少以及成本效益分析。在一组亚组患者中，我们还将通过评估外周血淋巴细胞中的急性染色体DNA损伤来评估剂量减少的放射生物学有效性。
NO-PARTY将确定使用EnSite NavX™标测系统引导的室上性快速心律失常射频导管消融术是否是一种合适且具有成本效益的方法，以实现患者和术者电离辐射暴露的临床显著减少。
