Atrial FibrillationRECORDAF-APNCT00995748
The RECORD Asia-Pacific Atrial Fibrillation Registry
An observational study of Atrial Fibrillation, run by Sanofi at 8 sites in 8 countries.
Trial summary
The Primary objective of this registry is to assess the control of Atrial Fibrillation (AF) over one year in patients attending clinical or specialized practices. The Secondary objectives are: To describe key demographics and treatment features in AF patients visiting cardiologists in various countries in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 2,674 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Apr 2009to Oct 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from office or hospital-based cardiologists from Asia-Pacific countries
Who may be able to join
- Patient presenting with either:
- History of atrial fibrillation diagnosed < 1 year by standard Electro-Cardiogram (ECG) or by ECG-Holter monitoring (treated or not or whatever rhythm at inclusion).
- New atrial fibrillation diagnosed by standard ECG or by ECG-Holter monitoring at inclusion visit.
- Patient eligible for a pharmacological treatment of AF (by rhythm or rate control agent).
Who cannot join
- AF due to transient cause (thyrotoxicosis, alcohol intoxication, acute phase of myocardial infarction, pericarditis, myocarditis, electrocution, pulmonary embolism or other pulmonary disease, hydroelectrolytic disorder, metabolic disorder, etc.).
- Post cardiac surgery AF (≤3 months).
- Mentally disabled patients unable to understand or sign the written informed consent.
- Patients unable to comply with follow-up visits.
- Patients with pacemaker, Implantable Cardioverter Defibrillator (ICD).
- Patients scheduled for pulmonary vein ablation, AV node/His bundle ablation, or pacemaker implantation.
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- Patient included in any clinical trial in the previous 3 months.
- Pregnant or breastfeeding women.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: REgistry on Cardiac Rhythm disORDers in Asia-Pacific
The Primary objective of this registry is to assess the control of Atrial Fibrillation (AF) over one year in patients attending clinical or specialized practices.
The Secondary objectives are:
- To describe key demographics and treatment features in AF patients visiting cardiologists in various countries in Asia-Pacific.
- To establish correlation between control of AF and clinical outcomes.
- To establish correlation between treatment strategies and AF control.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of therapeutic success by patients in sinus rhythm or heart rate control at target (< 80 beats per minute at rest)
Measured: At 12 ± 3 months follow-up
Comparison of clinical outcomes (Cardiovascular death, Stroke, Myocardial infarction, etc) for patients in rhythm versus rate control strategies
Measured: At 12 ± 3 months follow-up
Secondary outcomes (1)
Treatment effectiveness evaluated by the proportion of patients in sinus rhythm
Measured: At 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2011
- Study completionOct 2011
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 2,674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995748
- Sponsor's protocol ID
- DIREG_R_04434
- Acronym
- RECORDAF-AP
- Status last verified
- Feb 2012
- First submitted
- 14 Oct 2009
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REgistry on Cardiac Rhythm disORDers in Asia-Pacific
- ClinicalTrials.gov ID
- NCT00995748
- Acronym / sponsor ID
- RECORDAF-AP / DIREG_R_04434
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,674 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Oct 2009 (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.
The Primary objective of this registry is to assess the control of Atrial Fibrillation (AF) over one year in patients attending clinical or specialized practices.
The Secondary objectives are:
- To describe key demographics and treatment features in AF patients visiting cardiologists in various countries in Asia-Pacific.
- To establish correlation between control of AF and clinical outcomes.
- To establish correlation between treatment strategies and AF control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from office or hospital-based cardiologists from Asia-Pacific countries
Key inclusion criteria (4 listed)
- Patient presenting with either:
- Patient eligible for a pharmacological treatment of AF (by rhythm or rate control agent).
Key exclusion criteria (9 listed)
- AF due to transient cause (thyrotoxicosis, alcohol intoxication, acute phase of myocardial infarction, pericarditis, myocarditis, electrocution, pulmonary embolism or other pulmonary disease, hydroelectrolytic disorder, metabolic disorder, etc.).
- Post cardiac surgery AF (≤3 months).
- Mentally disabled patients unable to understand or sign the written informed consent.
- Patients unable to comply with follow-up visits.
- Patients with pacemaker, Implantable Cardioverter Defibrillator (ICD).
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
Rate of therapeutic success by patients in sinus rhythm or heart rate control at target (< 80 beats per minute at rest)
Time frame: At 12 ± 3 months follow-up
Comparison of clinical outcomes (Cardiovascular death, Stroke, Myocardial infarction, etc) for patients in rhythm versus rate control strategies
Time frame: At 12 ± 3 months follow-up
1 secondary outcome
Treatment effectiveness evaluated by the proportion of patients in sinus rhythm
Time frame: At 1 year follow-up
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 20 Feb 2012.
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Atrial Fibrillation (AF)
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.
Clinical Sciences & Operations study director
Sanofi
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Sanofi at 8 sites in 8 countries.
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 4 inclusion and 9 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 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, China, Hong Kong, Malaysia, Philippines and 3 more countries. 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?
Rate of therapeutic success by patients in sinus rhythm or heart rate control at target (< 80 beats per minute at rest) (time frame: At 12 ± 3 months follow-up). The study lists 2 primary outcomes in all. 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 20 Feb 2012.