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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00137540
First Posted: August 30, 2005
Last Update Posted: November 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biosense Webster, Inc. ( Biosense Webster EMEA )
  Purpose
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: None (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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137540


Locations
Italy
Ospedale Civile
Asti, Italy
Centro Cardiologico Monzino
Milan, Italy
Sponsors and Collaborators
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
  More Information

Responsible Party: Biosense Webster EMEA
ClinicalTrials.gov Identifier: NCT00137540     History of Changes
Other Study ID Numbers: FLAT
First Submitted: August 29, 2005
First Posted: August 30, 2005
Last Update Posted: November 4, 2014
Last Verified: November 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