Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation
Sponsor study identifier
interventional
200
1 country
1
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedThe purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 19, 2005
Actual (reported)To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hopital Cardiologique, Service de Cardiologique CHR de Lille
Lille, 59037, France
Salem Kacet
Hopital Cardiologique, CHR de Lille, France
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
February 7, 2022
Record last verified: 2006-09
Contact the study team to confirm eligibility.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: