Clinical trial NCT00995748: The RECORD Asia-Pacific Atrial Fibrillation Registry
Official title: REgistry on Cardiac Rhythm disORDers in Asia-Pacific
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-10-15
Enrollment: 2674
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from office or hospital-based cardiologists from Asia-Pacific countries

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.


Eligibility 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.

Primary outcomes:
measure: Rate of therapeutic success by patients in sinus rhythm or heart rate control at target (< 80 beats per minute at rest)
timeFrame: At 12 ± 3 months follow-up
measure: Comparison of clinical outcomes (Cardiovascular death, Stroke, Myocardial infarction, etc) for patients in rhythm versus rate control strategies
timeFrame: At 12 ± 3 months follow-up
Secondary outcomes:
measure: Treatment effectiveness evaluated by the proportion of patients in sinus rhythm
timeFrame: At 1 year follow-up
Other outcomes:
Locations:
city: Macquarie Park
country: Australia
facility: Sanofi-Aventis Administrative Office
city: Shanghai
country: China
facility: Sanofi-Aventis Administrative Office
city: Hong Kong
country: Hong Kong
facility: Sanofi-Aventis Administrative Office
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
city: Kuala Lumpur
country: Malaysia
facility: Sanofi-Aventis Administrative Office
city: Makati City
country: Philippines
facility: Sanofi-Aventis Administrative Office
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administrative Office
city: Bangkok
country: Thailand
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: