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

Completed

Phase N/A Results N/A

Trial Description

- 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.

Conditions

Interventions

  • AF Clinic Other
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: AF Clinic
  • Care as Usual Other
    Intervention Desc: Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.
    ARM 1: Kind: Experimental
    Label: Care as Usual

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. minimum of 1 year No
Secondary 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 No

Sponsors