Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Supraventricular Tachycardias
- Sponsor
- Catholic University of the Sacred Heart
- Enrollment
- 210
- Locations
- 6
- Primary Endpoint
- reduction of ionizing radiation exposure
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
reduction of ionizing radiation exposure
Time Frame: 1 day (radiation exposure will be evaluated at the end of procedure)
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
Secondary Outcomes
- Cost-Effectiveness(at 2 years)