To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation
Information source: MEDA Pharma GmbH & Co. KG
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Flecainide controlled release (Drug)
Phase: Phase 4
Sponsored by: MEDA Pharma GmbH & Co. KG
Official(s) and/or principal investigator(s):
Salem Kacet, Principal Investigator, Affiliation: Hopital Cardiologique, CHR de Lille, France
The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation
with controlled release flecainide on patient's quality of life.
Official title: Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).
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).
Minimum age: 18 Years.
Maximum age: 80 Years.
- 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
- 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
Locations and Contacts
Hopital Cardiologique, Service de Cardiologique CHR de Lille, Lille 59037, France
Starting date: September 2003
Last updated: February 20, 2007