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

This study has been completed.
Sponsor:
Collaborators:
St. Jude Medical Italy (Research Grant)
CNR Institute of Clinical Physiology, Pisa, Italy
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01132274
First received: March 4, 2010
Last updated: April 12, 2013
Last verified: April 2013

March 4, 2010
April 12, 2013
December 2009
March 2013   (final data collection date for primary outcome measure)
reduction of ionizing radiation exposure [ Time Frame: 1 day (radiation exposure will be evaluated at the end of procedure) ] [ Designated as safety issue: No ]
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
reduction of ionizing radiation exposure [ Time Frame: radiation exposure will be evaluated at the end of procedure ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01132274 on ClinicalTrials.gov Archive Site
  • Cost-Effectiveness [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    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.
  • Cost-Effectiveness [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Radiation Exposure Reduction in Supraventricular Tachycardia Ablation
Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Supraventricular Tachycardias
  • Procedure: Radiofrequency catheter ablation
    Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.
  • Procedure: Radiofrequency catheter ablation
    Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.
  • Active Comparator: Conventional catheter ablation
    Radiofrequency catheter ablation through fluoroscopic guidance
    Intervention: Procedure: Radiofrequency catheter ablation
  • Experimental: Non-fluoroscopic catheter ablation
    Radiofrequency catheter ablation guided by the EnSite NavX (St.Jude Medical, St Paul, MN, USA) mapping-system
    Intervention: Procedure: Radiofrequency catheter ablation
Casella M, Dello Russo A, Pelargonio G, Bongiorni MG, Del Greco M, Piacenti M, Andreassi MG, Santangeli P, Bartoletti S, Moltrasio M, Fassini G, Marini M, Di Cori A, Di Biase L, Fiorentini C, Zecchi P, Natale A, Picano E, Tondo C. Rationale and design of the NO-PARTY trial: near-zero fluoroscopic exposure during catheter ablation of supraventricular arrhythmias in young patients. Cardiol Young. 2012 Oct;22(5):539-46. doi: 10.1017/S1047951112000042. Epub 2012 Feb 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
14 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01132274
UCSC210210
Yes
Michela Casella, MD, PhD, Cardiac Arrhythmia Research Centre, Department of Cardiovascular Medicine, Centro Cardiologico Monzino, University of Milan, Milan, Italy
Catholic University of the Sacred Heart
  • St. Jude Medical Italy (Research Grant)
  • CNR Institute of Clinical Physiology, Pisa, Italy
Principal Investigator: Michela Casella, MD, PhD Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan, Milan, Italy
Catholic University of the Sacred Heart
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP