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

Phase 4

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT00189319
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Status Verified: 2006-09
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
assessment of treatment success based on an efficacy/safety composite criterion;
assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination;
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;
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).

Trial Locations

Locations (1)

Hopital Cardiologique, Service de Cardiologique CHR de Lille; 🇫🇷 Lille, France