NCT01856075

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,015

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

2.8 years

First QC Date

May 9, 2013

Last Update Submit

September 7, 2015

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationDronedaroneCohortEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Recurrence of Atrial Fibrillation

    Assessment of the recurrence of atrial fibrillation (change from baseline) at 3 month, 6 month, and 12-18 month of follow-up

    3 month; 6 month; 12-18 month

Secondary Outcomes (12)

  • Change from baseline Cardiovascular hospitalisation

    3 month; 6 month; 12-18 month

  • Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation

    3 month; 6 month; 12-18 month

  • Change from baseline Progression to permanent Atrial Fibrillation

    3 month; 6 month; 12-18 month

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

    3 month; 6 month; 12-18 month

  • Change from baseline Congestive heart failure

    3 month; 6 month; 12-18 month

  • +7 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxis fuer Kardiologie, Im Muehlenbach 2B

Bonn, 53127, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Artak Khachatryan, PhD

    LA-SER Europe

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 17, 2013

Study Start

October 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

DE(1)