Radiation Exposure Reduction in Supraventricular Tachycardia Ablation

Study Overview
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Brief Summary
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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.

Official Title
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Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias

Conditions
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Supraventricular Tachycardias

Intervention / Treatment
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* Procedure: Radiofrequency catheter ablation
* Procedure: Radiofrequency catheter ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional catheter ablation<br>Radiofrequency catheter ablation through fluoroscopic guidance | Procedure: Radiofrequency catheter ablation<br>* Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.<br>|
| Experimental: Non-fluoroscopic catheter ablation<br>Radiofrequency catheter ablation guided by the EnSite NavX (St.Jude Medical, St Paul, MN, USA) mapping-system | Procedure: Radiofrequency catheter ablation<br>* Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day (radiation exposure will be evaluated at the end of procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 1 year | 
| 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. | at 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraventricular arrhythmia catheter ablation