Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Effectiveness Study of Atrial Fibrillation (EFFECT-AF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
La-ser Europe Limited
ClinicalTrials.gov Identifier:
NCT01856075
First received: May 9, 2013
Last updated: September 7, 2015
Last verified: September 2015

May 9, 2013
September 7, 2015
October 2012
August 2015   (Final data collection date for primary outcome measure)
Change from baseline Recurrence of Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ]
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 ]
  • Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ]
  • Change from baseline Progression to permanent Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ]
  • Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction [ Time Frame: 3 month; 6 month; 12-18 month ]
  • Change from baseline Congestive heart failure [ Time Frame: 3 month; 6 month; 12-18 month ]
  • Change from baseline Interstitial pulmonary disease [ Time Frame: 3 month; 6 month; 12-18 month ]
  • Change from baseline Liver injury/toxicity [ Time Frame: 3 month; 6 month; 12-18 month ]
  • Change from baseline Renal insufficiency/failure [ Time Frame: 3 month; 6 month; 12-18 month ]
  • Change from baseline Cerebrovascular accident/Stroke [ Time Frame: 3 month; 6 month; 12-18 month ]
  • Change from baseline Myocardial infarction [ Time Frame: 3 month; 6 month; 12-18 month ]
  • Change from baseline Torsade de pointes [ Time Frame: 3 month; 6 month; 12-18 month ]
  • Death [ Time Frame: 3 month; 6 month; 12-18 month ]
    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.
 
Completed
1015
August 2015
August 2015   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01856075
Sanofi-EFFECT-AF
Yes
Not Provided
Not Provided
Not Provided
La-ser Europe Limited
La-ser Europe Limited
Not Provided
Study Director: Artak Khachatryan, PhD LA-SER Europe
La-ser Europe Limited
September 2015

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