Supraventricular Tachycardias Clinical Trial
— NO-PARTYOfficial title:
Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias
| Verified date | April 2013 |
| Source | Catholic University of the Sacred Heart |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 210 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 14 Years to 50 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan | Milan | |
| Italy | 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 | Catholic University of the Sacred Heart | Rome | |
| Italy | Institute of Cardiology; Presidio Ospedaliero Santa Chiara | Trento | TN |
| Lead Sponsor | Collaborator |
|---|---|
| Catholic University of the Sacred Heart | CNR Institute of Clinical Physiology, Pisa, Italy, St. Jude Medical Italy (Research Grant) |
Italy,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 1 day (radiation exposure will be evaluated at the end of procedure) | No |
| Secondary | 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. | at 1 year | No |
| Secondary | 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. | at 2 years | No |