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

Biosense Webster

Status and phase

Completed

Phase 3

Conditions

Atrial Fibrillation

Treatments

Drug: anti-arrhythmic drug therapy

Device: RF ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00137540

FLAT

Details and patient eligibility

About

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.

Full 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

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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