NCT00189319

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

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

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

February 7, 2022

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

February 4, 2022

Conditions

Atrial Fibrillation

Keywords

TambocorParoxysmal Atrial FibrillationQuality of Life

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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).

Interventions

Flecainide controlled releaseDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cardiologique, Service de Cardiologique CHR de Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Salem Kacet

    Hopital Cardiologique, CHR de Lille, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

September 1, 2003

Last Updated

February 7, 2022

Record last verified: 2006-09

Locations

FR(1)