Radiation Exposure Reduction in Supraventricular Tachycardia Ablation

Catholic University of the Sacred Heart210 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Supraventricular Tachycardias

Interventions

Eligibility

Sex: ALLMin age: 14 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (6)

Santa Maria della Misericordia - A.O. di Perugia

Perugia, PG, Italy

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

Catholic University of the Sacred Heart

Rome, Italy

Outcomes

Primary Outcomes

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

Time frame: 1 day (radiation exposure will be evaluated at the end of procedure)

Secondary Outcomes

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.

Time frame: at 1 year

Cost-Effectiveness

Time frame: at 2 years