Effectiveness Study of Atrial Fibrillation (EFFECT-AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by La-ser Europe Limited
Sponsor:
Information provided by (Responsible Party):
La-ser Europe Limited
ClinicalTrials.gov Identifier:
NCT01856075
First received: May 9, 2013
Last updated: May 16, 2013
Last verified: May 2013

May 9, 2013
May 16, 2013
October 2012
December 2014   (final data collection date for primary outcome measure)
Change from baseline Recurrence of Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: No ]
Assessment of the recurrence of atrial fibrillation (change from baseline) at 3 month, 6 month, and 12-18 month of follow-up
Same as current
Complete list of historical versions of study NCT01856075 on ClinicalTrials.gov Archive Site
  • Change from baseline Cardiovascular hospitalisation [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: No ]
  • Change from baseline Progression to permanent Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Congestive heart failure [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Interstitial pulmonary disease [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Liver injury/toxicity [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Renal insufficiency/failure [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Cerebrovascular accident/Stroke [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Myocardial infarction [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Torsade de pointes [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
    Assessed at each follow-up: 3 month, 6 month, and 12-18 month
Same as current
Not Provided
Not Provided
 
Effectiveness Study of Atrial Fibrillation
Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillation

This is an international observational multicentre study to be conducted in Germany, Spain, Italy and USA. The main objective of the study is to evaluate the relative effectiveness of dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest. The design of the study is a historic-prospective cohort with dynamic exposure and stratified competitive recruitment with balanced comparison groups of dronedarone versus alternative antiarrhythmic drugs of interest.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

This is an international observational multicentre study to be conducted in the following four countries: Germany, Spain, Italy and USA. Patients will be will be recruited from cardiology clinics, both hospital and non-hospital based, depending on particulars of treatment pathway of ppAF patients in each country.

Atrial Fibrillation
Not Provided
  • Patients treated with dronedarone
    Patients treated with dronedarone at inclusion
  • Patients treated with other antiarrhythmic drugs of interest

    The antiarrhythmic drugs of interest to which dronedarone will be compared are:

    • Class 1a/1c antiarrhythmics
    • Sotalol
    • Amiodarone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient 18 years old or above
  • Patient with paroxysmal or persistent atrial fibrillation
  • Patient using an AAi (antiarrhythmic drug of interest) or dronedarone (index drug)
  • Patient's treatment changed from one AAi to another AAi or dronedarone OR from no antiarrhythmic therapy to the start of AAi or dronedarone therapy during previous 6 months before the date of recruitment
  • Patient with at least 6 months of medical and treatment information prior to the start of the index drug
  • Patient able to answer the telephone interview in a language of the participating country: English, German, Italian or Spanish (with or without proxy).

Exclusion Criteria:

  • Patient with heart failure (NYHA class IV)
  • Patient with permanent Atrial Fibrillation
  • Patient with psychiatric conditions preventing the participation to the study according to the physician
Both
18 Years and older
No
Germany
 
NCT01856075
Sanofi-EFFECT-AF
Yes
La-ser Europe Limited
La-ser Europe Limited
Not Provided
Study Director: Artak Khachatryan, PhD LA-SER Europe
La-ser Europe Limited
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP