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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEDA Pharma GmbH & Co. KG
• Treatments: Flecainide

Criteria

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