Radiation Exposure Reduction in Supraventricular Tachycardia Ablation (NO-PARTY)
This study has been completed.
Sponsor:
Catholic University of the Sacred Heart
Collaborators:
St. Jude Medical Italy (Research Grant)
CNR Institute of Clinical Physiology, Pisa, Italy
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01132274
First received: March 4, 2010
Last updated: April 12, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Supraventricular Tachycardias |
Procedure: Radiofrequency catheter ablation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Near Zero Fluoroscopic Exposure During Catheter Ablation of Supraventricular Arrhythmias |
Further study details as provided by Catholic University of the Sacred Heart:
Primary Outcome Measures:
- reduction of ionizing radiation exposure [ Time Frame: 1 day (radiation exposure will be evaluated at the end of procedure) ] [ Designated as safety issue: No ]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 [ Time Frame: at 1 year ] [ Designated as safety issue: No ]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 [ Time Frame: at 2 years ] [ Designated as safety issue: No ]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.
| Enrollment: | 210 |
| Study Start Date: | December 2009 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Conventional catheter ablation
Radiofrequency catheter ablation through fluoroscopic guidance
|
Procedure: Radiofrequency catheter ablation
Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.
|
|
Experimental: Non-fluoroscopic catheter ablation
Radiofrequency catheter ablation guided by the EnSite NavX (St.Jude Medical, St Paul, MN, USA) mapping-system
|
Procedure: Radiofrequency catheter ablation
Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.
|
Eligibility| Ages Eligible for Study: | 14 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132274
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132274
Locations
| Italy | |
| Santa Maria della Misericordia - A.O. di Perugia | |
| Perugia, PG, Italy, 06156 | |
| 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, 20138 | |
| Catholic University of the Sacred Heart | |
| Rome, Italy, 00198 | |
Sponsors and Collaborators
Catholic University of the Sacred Heart
St. Jude Medical Italy (Research Grant)
CNR Institute of Clinical Physiology, Pisa, Italy
Investigators
| Principal Investigator: | Michela Casella, MD, PhD | Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino, University of Milan, Milan, Italy |
More Information
Publications:
| Responsible Party: | Michela Casella, MD, PhD, Cardiac Arrhythmia Research Centre, Department of Cardiovascular Medicine, Centro Cardiologico Monzino, University of Milan, Milan, Italy |
| ClinicalTrials.gov Identifier: | NCT01132274 History of Changes |
| Other Study ID Numbers: | UCSC210210 |
| Study First Received: | March 4, 2010 |
| Last Updated: | April 12, 2013 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Catholic University of the Sacred Heart:
|
Supraventricular arrhythmia catheter ablation |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Supraventricular Arrhythmias, Cardiac |
Cardiovascular Diseases Heart Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on February 27, 2015