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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00753259
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : April 20, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
  • 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.

Condition or disease Intervention/treatment
Atrial Fibrillation Other: AF Clinic Other: Care as Usual

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.
Study Start Date : June 2006
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AF Clinic 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
Active Comparator: Care as Usual Other: Care as Usual
Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.


Outcome Measures

Primary Outcome Measures :
  1. Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. [ Time Frame: minimum of 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed atrial fibrillation

Exclusion Criteria:

  • Age < 18 years
  • unwillingness to participate
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753259


Locations
Netherlands
Martini Hospital Groningen
Groningen, Netherlands, 9700 RM
MaastrichtUMC
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Robert G Tieleman, MD PhD Maastricht UMC
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr RG Tieleman, MD, PhD, Dept of Cardiology, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00753259     History of Changes
Other Study ID Numbers: MEC 06-4-043
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: April 20, 2010
Last Verified: April 2010

Keywords provided by Maastricht University Medical Center:
atrial fibrillation
disease management program
integrated chronic care program
guideline
stroke
heart failure
quality of life
costs

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes