abnormal heart rhythm a-fib
Conditions
Interventions
The intervention under study in this proposal is aimed at participating primary
care practices. All AF patients not having one of the aforementioned exclusion
criteria and registered within this pra
Sponsors
Isala Klinieken Zwolle
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: patients with atrial fibrillation of whom the GPs will provide integral management of AF and 65 years and over.
Exclusion criteria
Exclusion criteria: -unwilling to provide informed consent by the general practitioner -life expectancy less than 3 months -have an internal ICD or or a Cardiac Resynchronisation Therapy (CRT) device -had a cardiac resynchronization treatment, cardiac ablation or cardiac surgery less than 3 months prior to inclusion, or one of these procedures planned -heart valve surgery in the past -a rheumatic mitral valve stenosis -pulmonary vein isolation in the past, or planned -if they are legally incapable of providing informed consent for the intervention program -if they participate in another randomized trial about AF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint: The primary outcome for this study is all-cause mortality during the study duration of 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are cardiovascular death and cardiovascular hospitalization, non-cardiac hospitalization, Major Cardiac Adverse Events (MACE, defined as myocardial infarction, acute heart failure, stroke and major bleeding), quality of life, and cost-effectiveness. At the end of the study, an independent and blinded adjudication committee will adjudicate each hospitalization and death presumed to be related to the intervention, to assess the underlying causes. A cost-effectiveness analysis will be performed from the societal perspective. Actual health care expenses will be calculated from data in the electronic patient files (for example from data on hospitalisation) and will be used together with the QALYs to calculate the incremental cost-effectiveness ratio (ICER). Differences in costs result from hospitalization, from medical visits and diagnostic procedures, from treatment of stroke and thrombosis and bleeding complications, and from productivity losses associated with cardiovascular or thrombotic events and bleeding complications. The time horizon used for the economic evaluation will be equal to the study period, i.e. a follow-up period of 24 months after entrance in the study. | — |
Countries
Netherlands
Outcome results
None listed