First-line Treatment for Atrial Fibrillation in Cardiolog... | NCT02884661

Studies
First-line Treatment for Atrial Fibrillation in Cardiology and Geriatric Departments

NCT02884661

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Aug 31, 2016Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

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

Aug 2016

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

Oct 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Aug 26, 2016

First Submission Date that Met QC Criteria

Aug 26, 2016

First Posted Date

Aug 31, 2016Estimated

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

Aug 26, 2016

Last Update Posted Date

Aug 31, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In order to evaluate the implementation for the recommendations about the patient care for atrial fibrillation in aged patients, a non-interventional study is performed retrospectively by comparing two approach of the focus in Cardiology Department and in Geriatric unit.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hospitalization in Cardiology department		Patients cared by the Cardiology department
Hospitalization in Geriatric unit		Patients cared by the Geriatric unit

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implementation of the recommendations about non-valvular atrial fibrillation		September 1st, 2014 to October 13, 2015

Secondary Outcomes

Measure	Description	Time Frame
Socio-demographic data		September 1st, 2014 to October 13, 2015
Etiologic factors of the atrial fibrillations		September 1st, 2014 to October 13, 2015
Use of supplementary examinations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

having an atrial fibrillation
cared in Cardiology department or in geriatric unit

Exclusion Criteria:

having a mitral valvulopathy, or a valvular disease with a surgery indication
having a valvular prosthesis
history of valve reconstruction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients with an atrial fibrillation and hospitalized in Cardiology department or in geriatric unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
NOEL BLETTNER, MD	CHR Metz-Thionville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHR Metz-Thionville		Metz		57085	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