Atrial Fibrillation
Conditions
Keywords
First line ablation therapy
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
Interventions
DEVICERF ablation
Sponsors
Biosense Webster EMEA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| long-term success | 19 months |
Secondary
| Measure | Time frame |
|---|---|
| AF-burden | 19 months |
| health-economic costs | 24 months |
| serious adverse events | 19 months |
| Quality of Life scores | 19 months |
Outcome results
None listed