NCT00995748CompletedNot Applicable
REgistry on Cardiac Rhythm disORDers in Asia-Pacific
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 2,674
- Locations
- 1
- Primary Endpoint
- Rate of therapeutic success by patients in sinus rhythm or heart rate control at target (< 80 beats per minute at rest)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Treatment effectiveness evaluated by the proportion of patients in sinus rhythm(At 1 year follow-up)
Investigators
Study Sites (1)
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