The RECORD Asia-Pacific Atrial Fibrillation Registry

Atrial Fibrillation Clinical Trial

— RECORDAF-AP  

Official title:

REgistry on Cardiac Rhythm disORDers in Asia-Pacific

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995748
• Other study ID #: DIREG_R_04434
• Status: Completed
• Phase: N/A
• First received: October 14, 2009
• Last updated: February 16, 2012
• Start date: April 2009
• Est. completion date: October 2011

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2674
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Australia,  China,  Hong Kong,  Korea, Republic of,  Malaysia,  Philippines,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Comparison of clinical outcomes (Cardiovascular death, Stroke, Myocardial infarction, etc) for patients in rhythm versus rate control strategies		At 12 ± 3 months follow-up	No
Secondary	Treatment effectiveness evaluated by the proportion of patients in sinus rhythm		At 1 year follow-up	No