The RECORD Asia-Pacific Atrial Fibrillation Registry | NCT00995748

Studies
The RECORD Asia-Pacific Atrial Fibrillation Registry

NCT00995748

Sponsor

Sanofi

Status

Completed

Last Update Posted

Feb 20, 2012Estimated

Enrollment

2,674Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

Australia
China
Hong Kong
Malaysia
Philippines
South Korea
Taiwan
Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Oct 14, 2009

First Submission Date that Met QC Criteria

Oct 14, 2009

First Posted Date

Oct 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2012

Last Update Posted Date

Feb 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,674Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
Comparison of clinical outcomes (Cardiovascular death, Stroke, Myocardial infarction, etc) for patients in rhythm versus rate control strategies		At 12 ± 3 months follow-up

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Macquarie Park			Australia
Sanofi-Aventis Administrative Office

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes