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

This study has been terminated.
Sponsor:
Information provided by:
Biosense Webster EMEA
ClinicalTrials.gov Identifier:
NCT00137540
First received: August 29, 2005
Last updated: January 17, 2007
Last verified: January 2007
  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 4

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

Resource links provided by NLM:


Further study details as provided by Biosense Webster EMEA:

Primary Outcome Measures:
  • long-term success

Secondary Outcome Measures:
  • AF-burden
  • health-economic costs over 24 months
  • serious adverse events
  • Quality of Life scores

Estimated Enrollment: 40
Study Start Date: September 2005
Estimated Study Completion Date: July 2008
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00137540     History of Changes
Other Study ID Numbers: FLAT
Study First Received: August 29, 2005
Last Updated: January 17, 2007
Health Authority: Italy: Ministry of Health

Keywords provided by Biosense Webster EMEA:
First line ablation therapy

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014