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

Meda Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Flecainide controlled release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189319

1478-FLEC

Details and patient eligibility

About

The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)