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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
RF ablation
anti-arrhythmic drug therapy
Sponsored by
Biosense Webster EMEA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring First line ablation therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Civile
  • Centro Cardiologico Monzino

Outcomes

Primary Outcome Measures

long-term success

Secondary Outcome Measures

AF-burden
health-economic costs
serious adverse events
Quality of Life scores

Full Information

First Posted
August 29, 2005
Last Updated
November 3, 2014
Sponsor
Biosense Webster EMEA
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1. Study Identification

Unique Protocol Identification Number
NCT00137540
Brief Title
FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)
Official Title
First Line Radiofrequency Ablation vs. Antiarrhythmic Drugs for Atrial Fibrillation Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster EMEA

4. Oversight

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
First line ablation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
RF ablation
Intervention Type
Drug
Intervention Name(s)
anti-arrhythmic drug therapy
Primary Outcome Measure Information:
Title
long-term success
Time Frame
19 months
Secondary Outcome Measure Information:
Title
AF-burden
Time Frame
19 months
Title
health-economic costs
Time Frame
24 months
Title
serious adverse events
Time Frame
19 months
Title
Quality of Life scores
Time Frame
19 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. Gaita, Prof.
Organizational Affiliation
Ospedale Civile, Asti, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P. Della Bella, MD
Organizational Affiliation
Centro Cardiologico Monzino, Milan, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M. Fiala, MD
Organizational Affiliation
Nemocnice Podlesi, Trinec, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Civile
City
Asti
Country
Italy
Facility Name
Centro Cardiologico Monzino
City
Milan
Country
Italy

12. IPD Sharing Statement

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

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