Clinical trial NCT00137540: FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)
Official title: First Line Radiofrequency Ablation vs. Antiarrhythmic Drugs for Atrial Fibrillation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: First line ablation therapy
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: long-term success
timeFrame: 19 months
Secondary outcomes:
measure: AF-burden
timeFrame: 19 months
measure: health-economic costs
timeFrame: 24 months
measure: serious adverse events
timeFrame: 19 months
measure: Quality of Life scores
timeFrame: 19 months
Other outcomes:
Locations:
Study officials:
affiliation: Ospedale Civile, Asti, Italy
name: F. Gaita, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Cardiologico Monzino, Milan, Italy
name: P. Della Bella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nemocnice Podlesi, Trinec, Czech Republic
name: M. Fiala, MD
role: PRINCIPAL_INVESTIGATOR
References: