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

This study has been completed.
Information provided by (Responsible Party):
Biosense Webster, Inc. ( Biosense Webster EMEA ) Identifier:
First received: August 29, 2005
Last updated: November 3, 2014
Last verified: November 2014
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.

Condition Intervention Phase
Atrial Fibrillation Device: RF ablation Drug: anti-arrhythmic drug therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: First Line Radiofrequency Ablation vs. Antiarrhythmic Drugs for Atrial Fibrillation Treatment

Resource links provided by NLM:

Further study details as provided by Biosense Webster, Inc. ( Biosense Webster EMEA ):

Primary Outcome Measures:
  • long-term success [ Time Frame: 19 months ]

Secondary Outcome Measures:
  • AF-burden [ Time Frame: 19 months ]
  • health-economic costs [ Time Frame: 24 months ]
  • serious adverse events [ Time Frame: 19 months ]
  • Quality of Life scores [ Time Frame: 19 months ]

Enrollment: 40
Study Start Date: September 2005
Study Completion Date: July 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.


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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00137540

Ospedale Civile
Asti, Italy
Centro Cardiologico Monzino
Milan, Italy
Sponsors and Collaborators
Biosense Webster EMEA
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
  More Information

Responsible Party: Biosense Webster EMEA Identifier: NCT00137540     History of Changes
Other Study ID Numbers: FLAT
Study First Received: August 29, 2005
Last Updated: November 3, 2014

Keywords provided by Biosense Webster, Inc. ( Biosense Webster EMEA ):
First line ablation therapy

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents processed this record on July 19, 2017