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The RECORD Asia-Pacific Atrial Fibrillation Registry (RECORDAF-AP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00995748
First received: October 14, 2009
Last updated: February 16, 2012
Last verified: February 2012
History of Changes

October 14, 2009
February 16, 2012
April 2009
October 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00995748 on ClinicalTrials.gov Archive Site
Treatment effectiveness evaluated by the proportion of patients in sinus rhythm [ Time Frame: At 1 year follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The RECORD Asia-Pacific Atrial Fibrillation Registry
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients from office or hospital-based cardiologists from Asia-Pacific countries
Atrial Fibrillation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2674
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   China,   Hong Kong,   Korea, Republic of,   Malaysia,   Philippines,   Taiwan,   Thailand
 
NCT00995748
DIREG_R_04434
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP