The RECORD Asia-Pacific Atrial Fibrillation Registry (RECORDAF-AP)
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00995748
First received: October 14, 2009
Last updated: February 16, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Atrial Fibrillation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | REgistry on Cardiac Rhythm disORDers in Asia-Pacific |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Treatment effectiveness evaluated by the proportion of patients in sinus rhythm [ Time Frame: At 1 year follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 2674 |
| Study Start Date: | April 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients from office or hospital-based cardiologists from Asia-Pacific countries
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995748
Locations
| Australia | |
| Sanofi-Aventis Administrative Office | |
| Macquarie Park, Australia | |
| China | |
| Sanofi-Aventis Administrative Office | |
| Shanghai, China | |
| Hong Kong | |
| Sanofi-Aventis Administrative Office | |
| Hong Kong, Hong Kong | |
| Korea, Republic of | |
| Sanofi-Aventis Administrative Office | |
| Seoul, Korea, Republic of | |
| Malaysia | |
| Sanofi-Aventis Administrative Office | |
| Kuala Lumpur, Malaysia | |
| Philippines | |
| Sanofi-Aventis Administrative Office | |
| Makati City, Philippines | |
| Taiwan | |
| Sanofi-Aventis Administrative Office | |
| Taipei, Taiwan | |
| Thailand | |
| Sanofi-Aventis Administrative Office | |
| Bangkok, Thailand | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00995748 History of Changes |
| Other Study ID Numbers: | DIREG_R_04434 |
| Study First Received: | October 14, 2009 |
| Last Updated: | February 16, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013