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

Atrial Fibrillation Clinical Trial

Official title:

First Line Radiofrequency Ablation vs. Antiarrhythmic Drugs for Atrial Fibrillation Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137540
• Other study ID #: FLAT
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: November 3, 2014
• Start date: September 2005
• Est. completion date: July 2008

Study information

• Verified date: November 2014
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• RF ablation

Drug:
• anti-arrhythmic drug therapy

Locations

Country	Name	City	State
Italy	Ospedale Civile	Asti
Italy	Centro Cardiologico Monzino	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster EMEA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	long-term success		19 months	Yes
Secondary	AF-burden		19 months	No
Secondary	health-economic costs		24 months	No
Secondary	serious adverse events		19 months	Yes
Secondary	Quality of Life scores		19 months	No