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

Primary Purpose

Supraventricular Tachycardias

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Radiofrequency catheter ablation
Radiofrequency catheter ablation
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supraventricular Tachycardias focused on measuring Supraventricular arrhythmia catheter ablation

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Santa Maria della Misericordia - A.O. di Perugia
  • Arrhythmia Department, Azienda Ospedaliero-Universitaria Pisana
  • CNR, Institute of Clinical Physiology, Fondazione G. Monasterio
  • Institute of Cardiology; Presidio Ospedaliero Santa Chiara
  • Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan
  • Catholic University of the Sacred Heart

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional catheter ablation

Non-fluoroscopic catheter ablation

Arm Description

Radiofrequency catheter ablation through fluoroscopic guidance

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

Outcomes

Primary Outcome Measures

reduction of ionizing radiation exposure
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

Cost-Effectiveness
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
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.

Full Information

First Posted
March 4, 2010
Last Updated
April 12, 2013
Sponsor
Catholic University of the Sacred Heart
Collaborators
Abbott Medical Devices, CNR Institute of Clinical Physiology, Pisa, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01132274
Brief Title
Radiation Exposure Reduction in Supraventricular Tachycardia Ablation
Acronym
NO-PARTY
Official Title
Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
Abbott Medical Devices, CNR Institute of Clinical Physiology, Pisa, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraventricular Tachycardias
Keywords
Supraventricular arrhythmia catheter ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional catheter ablation
Arm Type
Active Comparator
Arm Description
Radiofrequency catheter ablation through fluoroscopic guidance
Arm Title
Non-fluoroscopic catheter ablation
Arm Type
Experimental
Arm Description
Radiofrequency catheter ablation guided by the EnSite NavX (St.Jude Medical, St Paul, MN, USA) mapping-system
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency catheter ablation
Intervention Description
Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency catheter ablation
Intervention Description
Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.
Primary Outcome Measure Information:
Title
reduction of ionizing radiation exposure
Description
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
Time Frame
1 day (radiation exposure will be evaluated at the end of procedure)
Secondary Outcome Measure Information:
Title
Cost-Effectiveness
Description
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.
Time Frame
at 1 year
Title
Cost-Effectiveness
Description
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.
Time Frame
at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michela Casella, MD, PhD
Organizational Affiliation
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan, Milan, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Maria della Misericordia - A.O. di Perugia
City
Perugia
State/Province
PG
ZIP/Postal Code
06156
Country
Italy
Facility Name
Arrhythmia Department, Azienda Ospedaliero-Universitaria Pisana
City
Pisa
State/Province
PI
Country
Italy
Facility Name
CNR, Institute of Clinical Physiology, Fondazione G. Monasterio
City
Pisa
State/Province
PI
Country
Italy
Facility Name
Institute of Cardiology; Presidio Ospedaliero Santa Chiara
City
Trento
State/Province
TN
Country
Italy
Facility Name
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan
City
Milan
ZIP/Postal Code
20138
Country
Italy
Facility Name
Catholic University of the Sacred Heart
City
Rome
ZIP/Postal Code
00198
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22325367
Citation
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.
Results Reference
background
PubMed Identifier
26559916
Citation
Casella M, Dello Russo A, Pelargonio G, Del Greco M, Zingarini G, Piacenti M, Di Cori A, Casula V, Marini M, Pizzamiglio F, Zucchetti M, Riva S, Russo E, Narducci ML, Soldati E, Panchetti L, Startari U, Bencardino G, Perna F, Santangeli P, Di Biase L, Cichocki F, Fattore G, Bongiorni M, Picano E, Natale A, Tondo C. Near zerO fluoroscopic exPosure during catheter ablAtion of supRavenTricular arrhYthmias: the NO-PARTY multicentre randomized trial. Europace. 2016 Oct;18(10):1565-1572. doi: 10.1093/europace/euv344. Epub 2015 Nov 10.
Results Reference
derived

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Radiation Exposure Reduction in Supraventricular Tachycardia Ablation

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