Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation. (AFClinic)
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|ClinicalTrials.gov Identifier: NCT00753259|
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : April 20, 2010
- 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||Phase|
|Atrial Fibrillation||Other: AF Clinic Other: Care as Usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||712 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
|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.
- Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. [ Time Frame: minimum of 1 year ]
- 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 ]
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
|Martini Hospital Groningen|
|Groningen, Netherlands, 9700 RM|
|Maastricht, Netherlands, 6202 AZ|
|Principal Investigator:||Robert G Tieleman, MD PhD||Maastricht UMC|