FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biosense Webster EMEA
• Treatments: Anti-Arrhythmia Agents

Criteria

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