Radiation Exposure Reduction in Supraventricular Tachycardia Ablation (NO-PARTY)

Catholic University of the Sacred Heart

Status and phase: Completed; Phase 4

Conditions: Supraventricular Tachycardias

Treatments: Procedure: Radiofrequency catheter ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01132274

UCSC210210

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 14 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Conventional catheter ablation

Active Comparator group

Description:

Radiofrequency catheter ablation through fluoroscopic guidance

Treatment:

Procedure: Radiofrequency catheter ablation

Procedure: Radiofrequency catheter ablation

Non-fluoroscopic catheter ablation

Experimental group

Description:

Radiofrequency catheter ablation guided by the EnSite NavX (St.Jude Medical, St Paul, MN, USA) mapping-system

Treatment:

Procedure: Radiofrequency catheter ablation

Procedure: Radiofrequency catheter ablation