Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137540
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2005-08-29
Brief Title:
FLAT Study First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation RAAFT
Sponsor:
Biosense Webster EMEA
Organization:
Biosense Webster Inc
Study Overview
Official Title:
First Line Radiofrequency Ablation vs Antiarrhythmic Drugs for Atrial Fibrillation Treatment
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None