Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00995748




Registration number
NCT00995748
Ethics application status
Date submitted
14/10/2009
Date registered
15/10/2009
Date last updated
20/02/2012

Titles & IDs
Public title
The RECORD Asia-Pacific Atrial Fibrillation Registry
Scientific title
REgistry on Cardiac Rhythm disORDers in Asia-Pacific
Secondary ID [1] 0 0
DIREG_R_04434
Universal Trial Number (UTN)
Trial acronym
RECORDAF-AP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of therapeutic success by patients in sinus rhythm or heart rate control at target (< 80 beats per minute at rest)
Timepoint [1] 0 0
At 12 ± 3 months follow-up
Primary outcome [2] 0 0
Comparison of clinical outcomes (Cardiovascular death, Stroke, Myocardial infarction, etc) for patients in rhythm versus rate control strategies
Timepoint [2] 0 0
At 12 ± 3 months follow-up
Secondary outcome [1] 0 0
Treatment effectiveness evaluated by the proportion of patients in sinus rhythm
Timepoint [1] 0 0
At 1 year follow-up

Eligibility
Key inclusion criteria
- 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
2674
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Shanghai
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Hong Kong
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Malaysia
State/province [4] 0 0
Kuala Lumpur
Country [5] 0 0
Philippines
State/province [5] 0 0
Makati City
Country [6] 0 0
Taiwan
State/province [6] 0 0
Taipei
Country [7] 0 0
Thailand
State/province [7] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 Asia-Pacific.

- To establish correlation between control of AF and clinical outcomes.

- To establish correlation between treatment strategies and AF control.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00995748
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00995748