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NCT Number: NCT01132274

Radiation Exposure Reduction in Supraventricular Tachycardia Ablation

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.

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Key information

Conditions

Supraventricular Tachycardias Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Supraventricular

Age range

14 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiofrequency catheter ablation

Procedure

Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.

Primary outcomes

  1. 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

  1. Cost-Effectiveness

    Time frame: 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.

  2. Cost-Effectiveness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Collaborators

  • Abbott Medical Devices
  • CNR Institute of Clinical Physiology, Pisa, Italy

Registry information

Official study title

Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias

Acronym: NO-PARTY

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
May 28, 2010
Registry last updated
Apr 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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