To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189319
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 21, 2007
Information provided by:
MEDA Pharma GmbH & Co. KG

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Flecainide controlled release Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation
Study Start Date : September 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).

Secondary Outcome Measures :
  1. assessment of treatment success based on an efficacy/safety composite criterion;
  2. assessment of the relationship between QoL changes and outcomes related to safety and efficacy;
  3. assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography;
  4. assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination;
  5. 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).

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189319

Hopital Cardiologique, Service de Cardiologique CHR de Lille
Lille, France, 59037
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
Principal Investigator: Salem Kacet Hopital Cardiologique, CHR de Lille, France Identifier: NCT00189319     History of Changes
Other Study ID Numbers: 1478-FLEC
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: February 21, 2007
Last Verified: September 2006

Keywords provided by MEDA Pharma GmbH & Co. KG:
Paroxysmal Atrial Fibrillation
Quality of Life

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action