FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT00137540
- Lead Sponsor
- Biosense Webster EMEA
- Brief Summary
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.
- Detailed Description
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.
Hypothesis:
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.
Primary endpoint:
* 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.
Secondary endpoints:
* AF burden: frequency and duration of episodes
* health-economic costs over 24 months
* serious adverse events
* Quality of Life scores, using SF-36 questionnaire
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Informed consent obtained
- Two or more documented symptomatic paroxysmal atrial fibrillation episodes during the last 6 months. Episodes should last longer than 30 seconds.
- Patients should not be on anti-arrhythmic medication therapy (Class I, III or IV) for AF (other than for cardioversion) or are currently on antiarrhythmic drug (AAD) therapy for any other arrhythmia
- Patients who had a previous ablation for atrial fibrillation
- Patients who had presence of severe valvular disease, myocardial infarction and/ or cardiomyopathy
- Patients with a left atrial size more than 50 mm
- Patients who had more than 2 cardioversions
- Patients who have a history of AF for less than 3 months or more than one year
- Patients with solely asymptomatic AF
- Patients who have AF episodes triggered by another uniform arrhythmia
- Patients who actively abuse alcohol or other drugs, which may be causative of AF
- Patients with a tumor, or another abnormality which precludes catheter introduction
- Patients with a revascularization or other cardiac surgery within 6 months before study treatment
- Patients in whom appropriate vascular access is precluded
- Patients with a contraindication to treatment with warfarin or other bleeding diathesis participants in another investigational clinical or device trial
- Patients who are inaccessible for follow-up psychological problem that might limit compliance
- Patients who cannot or will not fulfill the follow-up or protocol requirements
- Pregnant women
- Patients with severe chronic obstructive pulmonary disease
- Patients with Wolff-Parkinson-White (WPW) syndrome
- Patients with renal failure requiring dialysis
- Patients with hepatic failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method long-term success 19 months
- Secondary Outcome Measures
Name Time Method health-economic costs 24 months AF-burden 19 months serious adverse events 19 months Quality of Life scores 19 months
Trial Locations
- Locations (2)
Centro Cardiologico Monzino
🇮🇹Milan, Italy
Ospedale Civile
🇮🇹Asti, Italy