Status:
COMPLETED
FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)
Lead Sponsor:
Biosense Webster EMEA
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00137540
Start Date
September 1 2005
End Date
July 1 2008
Last Update
February 3 2025
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