Radiation Exposure Reduction in Supraventricular Tachycardia Ablation

Phase 4

Completed

• Conditions: Supraventricular Tachycardias
• Interventions: Procedure: Radiofrequency catheter ablation

• Registration Number: NCT01132274
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-12
• Last Update Posted: 2013-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional catheter ablation	Radiofrequency catheter ablation	Radiofrequency catheter ablation through fluoroscopic guidance
Non-fluoroscopic catheter ablation	Radiofrequency catheter ablation	Radiofrequency catheter ablation guided by the EnSite NavX (St.Jude Medical, St Paul, MN, USA) mapping-system

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cost-Effectiveness	at 2 years	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.

Trial Locations

Locations (6)

Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan; 🇮🇹 Milan, Italy

Santa Maria della Misericordia - A.O. di Perugia; 🇮🇹 Perugia, PG, Italy

Arrhythmia Department, Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, PI, Italy

Institute of Cardiology; Presidio Ospedaliero Santa Chiara; 🇮🇹 Trento, TN, Italy

CNR, Institute of Clinical Physiology, Fondazione G. Monasterio; 🇮🇹 Pisa, PI, Italy

Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy