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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

February 20, 2007

Start Date ^ICMJE

September 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00189319 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

- 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).

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: Flecainide controlled release

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00189319

Responsible Party

Study ID Numbers ^ICMJE

1478-FLEC

Study Sponsor ^ICMJE

MEDA Pharma GmbH & Co. KG

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Salem Kacet

Hopital Cardiologique, CHR de Lille, France

Information Provided By

MEDA Pharma GmbH & Co. KG

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP