Rationale and design of the NO-PARTY trial: near-zero fluoroscopic exposure during catheter ablation of supraventricular arrhythmias in young patients.
BACKGROUND
Radiofrequency catheter ablation is the mainstay of therapy for supraventricular tachyarrhythmias. Conventional radiofrequency catheter ablation requires the use of fluoroscopy, thus exposing patients to ionising radiation. The feasibility and safety of non-fluoroscopic radiofrequency catheter ablation has been recently reported in a wide range of supraventricular tachyarrhythmias using the EnSite NavX™ mapping system. The NO-PARTY is a multi-centre, randomised controlled trial designed to test the hypothesis that catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system results in a clinically significant reduction in exposure to ionising radiation compared with conventional catheter ablation.


METHODS
The study will randomise 210 patients undergoing catheter ablation of supraventricular tachyarrhythmias to either a conventional ablation technique or one guided by the EnSite NavX™ mapping system. The primary end-point is the reduction of the radiation dose to the patient. Secondary end-points include procedural success, reduction of the radiation dose to the operator, and a cost-effectiveness analysis. In a subgroup of patients, we will also evaluate the radiobiological effectiveness of dose reduction by assessing acute chromosomal DNA damage in peripheral blood lymphocytes.


CONCLUSIONS
NO-PARTY will determine whether radiofrequency catheter ablation of supraventricular tachyarrhythmias guided by the EnSite NavX™ mapping system is a suitable and cost-effective approach to achieve a clinically significant reduction in ionising radiation exposure for both patient and operator.
Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy. michela.casella@ccfm.it
Michela
M
Casella
Antonio
A
Dello Russo
Gemma
G
Pelargonio
Maria Grazia
MG
Bongiorni
Maurizio
M
Del Greco
Marcello
M
Piacenti
Maria Grazia
MG
Andreassi
Pasquale
P
Santangeli
Stefano
S
Bartoletti
Massimo
M
Moltrasio
Gaetano
G
Fassini
Massimiliano
M
Marini
Andrea
A
Di Cori
Luigi
L
Di Biase
Cesare
C
Fiorentini
Paolo
P
Zecchi
Andrea
A
Natale
Eugenio
E
Picano
Claudio
C
Tondo
D000293:Adolescent; D000328:Adult; D018780:Body Surface Potential Mapping; D017115:Catheter Ablation / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005471:Fluoroscopy / Q000379:methods*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016343:Monitoring, Intraoperative / Q000379:methods*; D011829:Radiation Dosage; D013617:Tachycardia, Supraventricular / Q000000981:diagnostic imaging* / Q000503:physiopathology / Q000601:surgery; D016896:Treatment Outcome; D055815:Young Adult