NCT00995748

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

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,674

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
8 countries

8 active sites

Status
completed

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

2.5 years

First QC Date

October 14, 2009

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (8)

Sanofi-Aventis Administrative Office

Macquarie Park, Australia

Location

Sanofi-Aventis Administrative Office

Shanghai, China

Location

Sanofi-Aventis Administrative Office

Hong Kong, Hong Kong

Location

Sanofi-Aventis Administrative Office

Kuala Lumpur, Malaysia

Location

Sanofi-Aventis Administrative Office

Makati City, Philippines

Location

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

Sanofi-Aventis Administrative Office

Taipei, Taiwan

Location

Sanofi-Aventis Administrative Office

Bangkok, Thailand

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

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

Locations