Supraventricular Tachycardias Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment