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

February 16, 2012 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Atrial Fibrillation

Study Type

Observational

Enrollment (Actual)

2674

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Macquarie Park, Australia
    - Sanofi-Aventis Administrative Office
China
- - Shanghai, China
    - Sanofi-Aventis Administrative Office
Hong Kong
- - Hong Kong, Hong Kong
    - Sanofi-Aventis Administrative Office
Korea, Republic of
- - Seoul, Korea, Republic of
    - Sanofi-Aventis Administrative Office
Malaysia
- - Kuala Lumpur, Malaysia
    - Sanofi-Aventis Administrative Office
Philippines
- - Makati City, Philippines
    - Sanofi-Aventis Administrative Office
Taiwan
- - Taipei, Taiwan
    - Sanofi-Aventis Administrative Office
Thailand
- - Bangkok, Thailand
    - Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from office or hospital-based cardiologists from Asia-Pacific countries

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	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	At 12 ± 3 months follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment effectiveness evaluated by the proportion of patients in sinus rhythm Time Frame: At 1 year follow-up	At 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria