Atrial FibrillationACFANCT02884661
First-line Treatment for Atrial Fibrillation in Cardiology and Geriatric Departments
An observational study of Atrial Fibrillation, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with an atrial fibrillation and hospitalized in Cardiology department or in geriatric unit
Who may be able to join
- having an atrial fibrillation
- cared in Cardiology department or in geriatric unit
Who cannot join
- having a mitral valvulopathy, or a valvular disease with a surgery indication
- having a valvular prosthesis
- history of valve reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Usual Choice for a First-line Treatment in Case of Atrial Fibrillation : Comparison Between Cardiology Department and Geriatric Unit.
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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalization in Cardiology department | Patients cared by the Cardiology department | |
| Hospitalization in Geriatric unit | Patients cared by the Geriatric unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of the recommendations about non-valvular atrial fibrillation
Measured: September 1st, 2014 to October 13, 2015
Secondary outcomes (7)
Socio-demographic data
Measured: September 1st, 2014 to October 13, 2015
Etiologic factors of the atrial fibrillations
Measured: September 1st, 2014 to October 13, 2015
Use of supplementary examinations
Measured: September 1st, 2014 to October 13, 2015
Use of a standard geriatric assessment
Measured: September 1st, 2014 to October 13, 2015
Use of an assessment of the risks of thrombosis and bleeding
Measured: September 1st, 2014 to October 13, 2015
Choice of the anti-thrombosis treatment
Measured: September 1st, 2014 to October 13, 2015
Choice of the anti-arrhythmia treatment
Measured: September 1st, 2014 to October 13, 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NOEL BLETTNER, MD, Principal investigator, CHR Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884661
- Sponsor's protocol ID
- 2015-05Obs-CHRMT
- Acronym
- ACFA
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Usual Choice for a First-line Treatment in Case of Atrial Fibrillation : Comparison Between Cardiology Department and Geriatric Unit.
- ClinicalTrials.gov ID
- NCT02884661
- Acronym / sponsor ID
- ACFA / 2015-05Obs-CHRMT
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalization in Cardiology department | – | –Patients cared by the Cardiology department |
| Hospitalization in Geriatric unit | – | –Patients cared by the Geriatric unit |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with an atrial fibrillation and hospitalized in Cardiology department or in geriatric unit
Key inclusion criteria (2 listed)
- having an atrial fibrillation
- cared in Cardiology department or in geriatric unit
Key exclusion criteria (3 listed)
- having a mitral valvulopathy, or a valvular disease with a surgery indication
- having a valvular prosthesis
- history of valve reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Implementation of the recommendations about non-valvular atrial fibrillation
Time frame: September 1st, 2014 to October 13, 2015
7 secondary outcomes
Socio-demographic data
Time frame: September 1st, 2014 to October 13, 2015
Etiologic factors of the atrial fibrillations
Time frame: September 1st, 2014 to October 13, 2015
Use of supplementary examinations
Time frame: September 1st, 2014 to October 13, 2015
Use of a standard geriatric assessment
Time frame: September 1st, 2014 to October 13, 2015
Use of an assessment of the risks of thrombosis and bleeding
Time frame: September 1st, 2014 to October 13, 2015
Choice of the anti-thrombosis treatment
Time frame: September 1st, 2014 to October 13, 2015
Choice of the anti-arrhythmia treatment
Time frame: September 1st, 2014 to October 13, 2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NOEL BLETTNER, MD principal investigator
CHR Metz-Thionville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation of the recommendations about non-valvular atrial fibrillation (time frame: September 1st, 2014 to October 13, 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.