NCT01132274

Radiation Exposure Reduction in Supraventricular Tachycardia Ablation

Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 14 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Supraventricular Tachycardias

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-05-28
• Last updated: 2013-04-15

Locations

6 sites across 1 country: Italy