The RECORD Asia-Pacific Atrial Fibrillation Registry

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.

Completed

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi-Aventis Administrative Office, Macquarie Park, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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
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 outcomes

Treatment effectiveness evaluated by the proportion of patients in sinus rhythm

Time frame: At 1 year follow-up

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

REgistry on Cardiac Rhythm disORDers in Asia-Pacific

Acronym: RECORDAF-AP

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Oct 15, 2009
Registry last updated: Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed