NCT02190175

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 7, 2018

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

July 8, 2014

Last Update Submit

September 6, 2018

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • ST interval and repolarization measures of myocardia in patients under treatment of flecainide

    6months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Erythros Stavros Hospital

Athens, 11526, Greece

Location

University Hospital of Larisa

Larissa, 41110, Greece

Location

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 15, 2014

Study Start

June 1, 2014

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

September 7, 2018

Record last verified: 2017-03

Locations

GR(3)