The RECORD Asia-Pacific Atrial Fibrillation Registry
RECORDAF-AP
REgistry on Cardiac Rhythm disORDers in Asia-Pacific
1 other identifier
observational
2,674
8 countries
8
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Typical duration for all trials
8 active sites
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
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 14, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFebruary 20, 2012
February 1, 2012
2.5 years
October 14, 2009
February 16, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of therapeutic success by patients in sinus rhythm or heart rate control at target (< 80 beats per minute at rest)
At 12 ± 3 months follow-up
Comparison of clinical outcomes (Cardiovascular death, Stroke, Myocardial infarction, etc) for patients in rhythm versus rate control strategies
At 12 ± 3 months follow-up
Secondary Outcomes (1)
Treatment effectiveness evaluated by the proportion of patients in sinus rhythm
At 1 year follow-up
Eligibility Criteria
Patients from office or hospital-based cardiologists from Asia-Pacific countries
You may qualify if:
- Patient presenting with either:
- Patient eligible for a pharmacological treatment of AF (by rhythm or rate control agent).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (8)
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Sanofi-Aventis Administrative Office
Shanghai, China
Sanofi-Aventis Administrative Office
Hong Kong, Hong Kong
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Sanofi-Aventis Administrative Office
Makati City, Philippines
Sanofi-Aventis Administrative Office
Seoul, South Korea
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Sanofi-Aventis Administrative Office
Bangkok, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2009
First Posted
October 15, 2009
Study Start
April 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
February 20, 2012
Record last verified: 2012-02