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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: AF Clinic; Other: Care as Usual

• Registration Number: NCT00753259
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-19
• Last Update Posted: 2010-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 712

Inclusion Criteria

• Newly diagnosed atrial fibrillation

Exclusion Criteria

• Age < 18 years
• unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AF Clinic	AF Clinic	-
Care as Usual	Care as Usual	-

Primary Outcome Measures

Name	Time	Method
Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes.	minimum of 1 year

Secondary Outcome Measures

Name	Time	Method
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.	minimum of 1 year

Trial Locations

Locations (2)

Martini Hospital Groningen; 🇳🇱 Groningen, Netherlands

MaastrichtUMC; 🇳🇱 Maastricht, Netherlands