Status:
COMPLETED
To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation
Lead Sponsor:
MEDA Pharma GmbH & Co. KG
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.
Eligibility Criteria
Inclusion
- In sinus rhythm at treatment initiation
- Experienced symptomatic AF episodes
- Left ventricular ejection fraction of at least 40%
- Females of child bearing potential must be using reliable method of contraception
Exclusion
- Intolerance and/or failure of previous therapy with flecainide immediate release
- Currently receiving \>200mg/day flecainide immediate release
- Severe symptoms during episodes of arrhythmia
- History of other cardiac conditions/abnormalities
- Heart surgery within the last 2 months
- Renal failure
- Pregnant or lactating females
- Significant extra cardiac or systemic disease
- Abnormal electrolyte levels
- Receiving defined cardiac and/or other treatments
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00189319
Start Date
September 1 2003
Last Update
February 7 2022
Active Locations (1)
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1
Hopital Cardiologique, Service de Cardiologique CHR de Lille
Lille, France, 59037