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Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation. (AFClinic)

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00753259
First received: September 15, 2008
Last updated: April 19, 2010
Last verified: April 2010
History of Changes

September 15, 2008
April 19, 2010
June 2006
January 2010   (final data collection date for primary outcome measure)
Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. [ Time Frame: minimum of 1 year ] [ Designated as safety issue: No ]
Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00753259 on ClinicalTrials.gov Archive Site
All cause mortality, all cause hospitalizations, Treatment (benchmarking) in accordance to the 2006 AHA/ACC/ESC guidelines in AF, quality of life, patient satisfaction, anxiety, depression, compliance and cost effectiveness. [ Time Frame: minimum of 1 year ] [ Designated as safety issue: No ]
Treatment (benchmarking) in accordance to the 2006 AHA/ACC/ESC guidelines in AF, quality of life, patient satisfaction, anxiety, depression, compliance and cost effectiveness. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation.
The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.
  • Randomized controlled trial comparing specialized AF Clinic with 'care as usual'
  • Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • Other: AF Clinic
    Treatment of atrial fibrillation patients by specialized nurses, supervised by cardiologists, using dedicated software to ensure maximal adherence to AHA/ACC/ESC guidelines on atrial fibrillation treatment
  • Other: Care as Usual
    Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.
  • Experimental: AF Clinic
    Intervention: Other: AF Clinic
  • Active Comparator: Care as Usual
    Intervention: Other: Care as Usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
712
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Newly diagnosed atrial fibrillation

Exclusion Criteria:

  • Age < 18 years
  • unwillingness to participate
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00753259
MEC 06-4-043
No
Dr RG Tieleman, MD, PhD, Dept of Cardiology, Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Robert G Tieleman, MD PhD Maastricht UMC
Maastricht University Medical Center
April 2010

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