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

MEDA Pharma GmbH & Co. KG200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Atrial Fibrillation

Interventions

Flecainide controlled releaseDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hopital Cardiologique, Service de Cardiologique CHR de Lille

Lille, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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