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
  Purpose

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
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: REgistry on Cardiac Rhythm disORDers in Asia-Pacific

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Treatment effectiveness evaluated by the proportion of patients in sinus rhythm [ Time Frame: At 1 year follow-up ] [ Designated as safety issue: No ]

Enrollment: 2674
Study Start Date: April 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00995748     History of Changes
Other Study ID Numbers: DIREG_R_04434
Study First Received: October 14, 2009
Last Updated: February 16, 2012
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014