To Evaluate the Impact of Oral Flecainide on Quality of L... | NCT00189319

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

NCT00189319

Sponsor

MEDA Pharma GmbH & Co. KG

Status

Completed

Last Update Posted

Feb 7, 2022Actual

Enrollment

200

Phase

Phase 4

Conditions

Atrial Fibrillation

Interventions

Flecainide controlled release

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2022

Last Update Posted Date

Feb 7, 2022Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
Flecainide controlled release	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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;

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Salem Kacet	Hopital Cardiologique, CHR de Lille, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Cardiologique, Service de Cardiologique CHR de Lille		Lille		59037	France

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided