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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00995748
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : February 20, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease
Atrial Fibrillation

Study Type : Observational
Actual Enrollment : 2674 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: REgistry on Cardiac Rhythm disORDers in Asia-Pacific
Study Start Date : April 2009
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 ]
  2. 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 Outcome Measures :
  1. Treatment effectiveness evaluated by the proportion of patients in sinus rhythm [ Time Frame: At 1 year follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from office or hospital-based cardiologists from Asia-Pacific countries
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995748


Locations
Australia
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
China
Sanofi-Aventis Administrative Office
Shanghai, China
Hong Kong
Sanofi-Aventis Administrative Office
Hong Kong, Hong Kong
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Philippines
Sanofi-Aventis Administrative Office
Makati City, Philippines
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Thailand
Sanofi-Aventis Administrative Office
Bangkok, Thailand
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00995748     History of Changes
Other Study ID Numbers: DIREG_R_04434
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes