Clinical trial NCT01132274: Radiation Exposure Reduction in Supraventricular Tachycardia Ablation
Official title: Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Supraventricular Tachycardias
Keywords: Supraventricular arrhythmia catheter ablation
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: CNR Institute of Clinical Physiology, Pisa, Italy
First posted: 2010-05-28
Enrollment: 210
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: reduction of ionizing radiation exposure
timeFrame: 1 day (radiation exposure will be evaluated at the end of procedure)
Secondary outcomes:
measure: Cost-Effectiveness
timeFrame: at 1 year
measure: Cost-Effectiveness
timeFrame: at 2 years
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Santa Maria della Misericordia - A.O. di Perugia
state: PG
city: Pisa
country: Italy
facility: Arrhythmia Department, Azienda Ospedaliero-Universitaria Pisana
state: PI
city: Pisa
country: Italy
facility: CNR, Institute of Clinical Physiology, Fondazione G. Monasterio
state: PI
city: Trento
country: Italy
facility: Institute of Cardiology; Presidio Ospedaliero Santa Chiara
state: TN
city: Milan
country: Italy
facility: Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
affiliation: Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan, Milan, Italy
name: Michela Casella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.