FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)
The objective of this multicenter randomized study is to establish the effectiveness of treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation, using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic drug treatment, defined as patients with an absence of atrial tachycardias during 24 months of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead electrocardiogram (ECG) recordings.
Device: RF ablation
Drug: anti-arrhythmic drug therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||First Line Radiofrequency Ablation vs. Antiarrhythmic Drugs for Atrial Fibrillation Treatment|
- long-term success [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
- AF-burden [ Time Frame: 19 months ] [ Designated as safety issue: No ]
- health-economic costs [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- serious adverse events [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
- Quality of Life scores [ Time Frame: 19 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||July 2008|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
This study is a prospective, randomized, multicenter clinical study that will enroll in its first phase 40 patients. The study will be performed in 3 European hospitals. Patients will be randomized to either the RF ablation strategy or to the medication arm.
As first line therapy, catheter ablation improves the long-term success, health-economic outcomes and is equally safe compared to the best anti-arrhythmic medication treatment in a selected group of patients with paroxysmal atrial fibrillation.
- long-term success, defined as patients free from any atrial fibrillation during 24 months after initial study treatment as determined by 7-days Holter and transtelephonic monitoring and by 12-lead ECG recordings.
- AF burden: frequency and duration of episodes
- health-economic costs over 24 months
- serious adverse events
- Quality of Life scores, using SF-36 questionnaire
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137540
|Centro Cardiologico Monzino|
|Principal Investigator:||F. Gaita, Prof.||Ospedale Civile, Asti, Italy|
|Principal Investigator:||P. Della Bella, MD||Centro Cardiologico Monzino, Milan, Italy|
|Principal Investigator:||M. Fiala, MD||Nemocnice Podlesi, Trinec, Czech Republic|