Supraventricular Tachycardias
Conditions
Keywords
Supraventricular arrhythmia catheter ablation
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.
Interventions
PROCEDURERadiofrequency catheter ablation
Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.
Sponsors
Abbott Medical Devices
CNR Institute of Clinical Physiology, Pisa, Italy
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction of ionizing radiation exposure | 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
| Measure | Time frame | Description |
|---|---|---|
| Cost-Effectiveness | at 1 year | 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. |
Countries
Italy
Outcome results
None listed