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Completed

NCT Number: NCT00189319

To Evaluate the Impact of Oral Flecainide on Quality of Life 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Cardiologique, Service de Cardiologique CHR de Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flecainide controlled release

Drug

Primary outcomes

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

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

MEDA Pharma GmbH & Co. KG

Industry

Registry information

Official study title

Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation

Important dates

Study start
2003
First posted
Sep 19, 2005
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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