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OpenTrials
Completed

NCT Number: NCT01856075

Effectiveness Study 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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis fuer Kardiologie, Im Muehlenbach 2B

Bonn, 53127, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline Cardiovascular hospitalisation

    Time frame: 3 month; 6 month; 12-18 month

  2. Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation

    Time frame: 3 month; 6 month; 12-18 month

  3. Change from baseline Progression to permanent Atrial Fibrillation

    Time frame: 3 month; 6 month; 12-18 month

  4. Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction

    Time frame: 3 month; 6 month; 12-18 month

  5. Change from baseline Congestive heart failure

    Time frame: 3 month; 6 month; 12-18 month

  6. Change from baseline Interstitial pulmonary disease

    Time frame: 3 month; 6 month; 12-18 month

  7. Change from baseline Liver injury/toxicity

    Time frame: 3 month; 6 month; 12-18 month

  8. Change from baseline Renal insufficiency/failure

    Time frame: 3 month; 6 month; 12-18 month

  9. Change from baseline Cerebrovascular accident/Stroke

    Time frame: 3 month; 6 month; 12-18 month

  10. Change from baseline Myocardial infarction

    Time frame: 3 month; 6 month; 12-18 month

  11. Change from baseline Torsade de pointes

    Time frame: 3 month; 6 month; 12-18 month

  12. Death

    Time frame: 3 month; 6 month; 12-18 month

    Assessed at each follow-up: 3 month, 6 month, and 12-18 month

Sponsors and collaborators

Lead sponsor

La-ser Europe Limited

Other

Registry information

Official study title

Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillation

Acronym: EFFECT-AF

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 17, 2013
Registry last updated
Sep 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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