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OpenTrials
Completed

NCT Number: NCT00753259

Atrial Fibrillation (AF) Clinic 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.

Completed

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Heart Failure Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martini Hospital Groningen, Groningen, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed atrial fibrillation

Exclusion criteria

  • Age < 18 years
  • unwillingness to participate

Treatment and study plan

AF Clinic

Other

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

Other

Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.

Acronym: AFClinic

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2008
Registry last updated
Apr 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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