Atrial Fibrillation
Conditions
Keywords
Tambocor, Paroxysmal Atrial Fibrillation, Quality of Life
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.
Interventions
DRUGFlecainide controlled release
Sponsors
MEDA Pharma GmbH & Co. KG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life). | — |
Secondary
| Measure | Time frame |
|---|---|
| assessment of treatment success based on an efficacy/safety composite criterion; | — |
| assessment of the relationship between QoL changes and outcomes related to safety and efficacy; | — |
| assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography; | — |
| assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination; | — |
| evaluation of the course of the disease by the time to the first recurrence of a PAF episode and the subjective symptomatology (duration and severity of PAF episodes). | — |
Countries
France
Outcome results
None listed