Management of Atrial Fibrillation With Flecainide : the AFFLEC Study

September 6, 2018 updated by: Hellenic Cardiovascular Research Society

Multicentre Non Interventional Study in the Management of Atrial Fibrillation With Flecainide

This is a multicentre non interventional observational study with the objective to follow up patients with atrial fibrillation who based on current indications are treated with per os flecainide , for cardiac pulse maintenance.

Study Overview

Status

Completed

Conditions

Detailed Description

the study objectives are

  • record safety and efficiency of flecainide as antiarrythmic treatment in atrial fibrillation
  • study of flecainide in ST interval

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11526
        • Erythros Stavros Hospital
      • Larisa, Greece, 41110
        • University Hospital Of Larisa
      • Thessaloniki, Greece, 54636
        • Ahepa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with history of atrial fibrillation who are under treatment with per os flecainide

Description

Inclusion Criteria:

  • patients with history of atrial fibrillation
  • patients able to give informed consent

Exclusion Criteria:

  • patients with coronary disease or other cardiopathy with left heart champer affected

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ST interval and repolarization measures of myocardia in patients under treatment of flecainide
Time Frame: 6months
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Cardiovascular Research Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 15, 2014

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFFLEC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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