Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation. - Full Text View

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

This study is currently recruiting participants.

Verified by Maastricht University Medical Center, September 2008

First Received: September 15, 2008 Last Updated: September 22, 2008 History of Changes

Sponsored by:	Maastricht University Medical Center
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00753259

Purpose

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	Intervention
Atrial Fibrillation	Other: AF Clinic Other: Care as Usual

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Effect of a Nurse-Driven ICT-Supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	698
Study Start Date:	June 2006
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed atrial fibrillation

Exclusion Criteria:

Age < 18 years
unwillingness to participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753259

Contacts

Contact: Robert G Tieleman, MD, PhD	+31-50-5245245	r.tieleman@cardio.unimaas.nl
Contact: Jeroen Hendriks, BSc	+31-43-3876543	Jeroen.Hendriks@ZW.unimaas.nl

Locations

Netherlands
MaastrichtUMC	Recruiting
Maastricht, Netherlands, 6202 AZ
Contact: Robert G Tieleman, MD, PhD r.tieleman@cardio.unimaas.nl
Martini Hospital Groningen	Recruiting
Groningen, Netherlands, 9700 RM
Contact: Robert G Tieleman, MD, PhD +31-50-5245245 r.tieleman@cardio.unimaas.nl

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator:

Robert G Tieleman, MD PhD

Maastricht UMC

More Information

No publications provided

Responsible Party:	Dept of Cardiology, Maastricht University Medical Center ( Dr RG Tieleman, MD, PhD )
Study ID Numbers:	MEC 06-4-043
Study First Received:	September 15, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00753259 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:

atrial fibrillation
disease management program
integrated chronic care program
guideline

stroke
heart failure
quality of life
costs

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Cerebral Infarction
Stroke

Quality of Life
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on September 02, 2009