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

January 31, 2025 updated by: Biosense Webster EMEA

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

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.

Study Overview

Status

Completed

Conditions

Atrial Fibrillation

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Asti, Italy
    - Ospedale Civile
  - Milan, Italy
    - Centro Cardiologico Monzino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
long-term success Time Frame: 19 months	19 months

Secondary Outcome Measures

Outcome Measure	Time Frame
AF-burden Time Frame: 19 months	19 months
health-economic costs Time Frame: 24 months	24 months
serious adverse events Time Frame: 19 months	19 months
Quality of Life scores Time Frame: 19 months	19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosense Webster EMEA

Investigators

Principal Investigator: F. Gaita, Prof., Ospedale Civile, Asti, Italy
Principal Investigator: P. Della Bella, MD, Centro Cardiologico Monzino, Milan, Italy
Principal Investigator: M. Fiala, MD, Nemocnice Podlesi, Trinec, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria