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

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ClinicalTrials.gov Identifier: NCT01132274
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : April 15, 2013
Sponsor:
Collaborators:
Abbott Medical Devices
CNR Institute of Clinical Physiology, Pisa, Italy
Information provided by:
Catholic University of the Sacred Heart

Study Description
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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.


Condition or disease Intervention/treatment Phase
Supraventricular Tachycardias Procedure: Radiofrequency catheter ablation Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias
Study Start Date : December 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Conventional catheter ablation
Radiofrequency catheter ablation through fluoroscopic guidance
 Procedure: Radiofrequency catheter ablation
Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.
Experimental: Non-fluoroscopic catheter ablation
Radiofrequency catheter ablation guided by the EnSite NavX (St.Jude Medical, St Paul, MN, USA) mapping-system
 Procedure: Radiofrequency catheter ablation
Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132274


Locations
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Italy
Santa Maria della Misericordia - A.O. di Perugia
Perugia, PG, Italy, 06156
Arrhythmia Department, Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, Italy
CNR, Institute of Clinical Physiology, Fondazione G. Monasterio
Pisa, PI, Italy
Institute of Cardiology; Presidio Ospedaliero Santa Chiara
Trento, TN, Italy
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan
Milan, Italy, 20138
Catholic University of the Sacred Heart
Rome, Italy, 00198
Sponsors and Collaborators
Catholic University of the Sacred Heart
Abbott Medical Devices
CNR Institute of Clinical Physiology, Pisa, Italy
Investigators
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Principal Investigator: Michela Casella, MD, PhD Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan, Milan, Italy
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michela Casella, MD, PhD, Cardiac Arrhythmia Research Centre, Department of Cardiovascular Medicine, Centro Cardiologico Monzino, University of Milan, Milan, Italy
ClinicalTrials.gov Identifier: NCT01132274     History of Changes
Other Study ID Numbers: UCSC210210
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

Keywords provided by Catholic University of the Sacred Heart:
Supraventricular arrhythmia catheter ablation

Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes