NCT02884661

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.

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 Oct 2015

Shorter than P25 for all trials

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

October 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

August 26, 2016

Last Update Submit

August 26, 2016

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Implementation of the recommendations about non-valvular atrial fibrillation

    September 1st, 2014 to October 13, 2015

Secondary Outcomes (7)

  • 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

    September 1st, 2014 to October 13, 2015

  • Use of a standard geriatric assessment

    September 1st, 2014 to October 13, 2015

  • Use of an assessment of the risks of thrombosis and bleeding

    September 1st, 2014 to October 13, 2015

  • +2 more secondary outcomes

Study Arms (2)

Hospitalization in Cardiology department

Patients cared by the Cardiology department

Hospitalization in Geriatric unit

Patients cared by the Geriatric unit

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville

Metz, 57085, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • NOEL BLETTNER, MD

    CHR Metz-Thionville

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

FR(1)