Official Title: “Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation”

The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Flecainide controlled release

Primary Measures

• To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).

Secondary Measures

• 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).

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: MEDA Pharma GmbH & Co. KG

Overall Clinical Trial Officials and Contacts

Salem Kacet Principal Investigator Hopital Cardiologique, CHR de Lille, France  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00189319

Study ID Number: 1478-FLEC

ClinicalTrials.gov Identifier: NCT00189319

Health Authority: France: Afssaps - French Health Products Safety Agency