Radiation Exposure Reduction in Supraventricular Tachycardia Ablation

NCT ID: NCT01132274

Last Updated: 2013-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-03-31

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.

Conditions

Supraventricular Tachycardias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional catheter ablation

Radiofrequency catheter ablation through fluoroscopic guidance

Group Type: ACTIVE_COMPARATOR

Radiofrequency catheter ablation

Intervention Type: PROCEDURE

Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.

Non-fluoroscopic catheter ablation

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

Group Type: EXPERIMENTAL

Radiofrequency catheter ablation

Intervention Type: PROCEDURE

Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.

Interventions

Radiofrequency catheter ablation

Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.

Intervention Type: PROCEDURE

Radiofrequency catheter ablation

Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

CNR Institute of Clinical Physiology, Pisa, Italy

UNKNOWN

Sponsor Role: collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Cardiac Arrhythmia Research Centre, Department of Cardiovascular Medicine, Centro Cardiologico Monzino, University of Milan, Milan, Italy

Principal Investigators

Michela Casella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan, Milan, Italy

Locations

Santa Maria della Misericordia - A.O. di Perugia

Perugia, PG, Italy

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

Catholic University of the Sacred Heart

Rome, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 22325367 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26559916 (View on PubMed)

Other Identifiers

UCSC210210

Identifier Type: -

Identifier Source: org_study_id