'Atrial Fibrillation' 'Irregular heartbeat'
Conditions
Interventions
The intervention in this study contains the treatment through an integrated
chronic care program at the specialized AF clinic. The ICCP consists of a nurse
specialist, cardiologist, guidelines-based
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed AF detected on electrocardiogram (ECG), holter recordings or eventrecorder with a duration > 30 seconds, 3 months before inclusion; 2. Patients with a history of diagnosed AF, with no regular control at a cardiologist for AF in the last 2 years and referred by a non-cardiologic medical specialist for new diagnostics or therapeutic issue; 3. Age * 18 years.
Exclusion criteria
Exclusion criteria: 1. No electrocardiographic objectified AF; 2. Unstable heart failure defined as NYHA IV or heart failure necessitating hospital admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite, defined as unplanned admission to the hospital for any cardiovascular reason and cardiovascular death. The endpoint events leading to unplanned hospitalisation or death are therefore: 1. Left or right ventricular heart failure which is independent of LVEF (preferably confirmed by biomarker assessment using NT-pro-BNP) and requiring intravenous diuretics or an unplanned hospitalisation without admission when any adjustment of heart failure therapy suffices; 2. Ischemic thromboembolic complications including stroke (the sudden onset of a focal neurologic deficit in a location consistent with the territory of a major cerebral artery caused by an arterial thrombus in this artery, categorized as ischemic stroke and TIA (transient stroke, whereby clinical symptoms disappear within 24 hours))confirmed by a neurologist on the basis of computerised tomography or MRI; peripheral emboli, pulmonary emboli or systemic emboli (an acute vascular occlusion of an extremity or organ) documented by means of imaging, surgery or autopsy; 3. Acute coronary syndrome (STEMI/ NSTEMI/ unstable angina pectoris, with at least two of the following characteristics: (1) typical chest pain for at least 20 minutes; (2) ischemic electrocardiographic changes, and (3) cardiac enzyme elevation more than twice the upper limit of normal or instable angina pectoris, respectively documented on ECG as well as/ or only in blood levels of key chemical markers); 4. Major bleeding(an acute bleeding with the hemoglobin value decreased by > 20 g/ L (>2g/ dL; 1,2 mmol/l), or requiring blood transfusion of at least two units of blood, or a symptomatic bleeding in a critical organ or area (intra-cranial (intracerebral hemorrhage, subdural hemorrhage or subarachnoid hemorrhage), retroperitoneal, spinal, ocular, pericardial, or a traumatic articular) or fatal bleeding; 5. Arrhythmic or potential arrhythmic events (atrial fibrillation, -flutter, other su | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1. The cost benefit of the intervention by means of a cost effectiveness analysis; 2. The extent to which the comprehensive cardiovascular treatment is in accordance to the latest ESC guidelines for AF, HF guidelines of acute and chronic heart failure and CVD Prevention guidelines; 3. Patient quality of life and satisfaction; 4. Patient anxiety and/ or depression; 5. Patients* knowledge of AF and 6. Patients* compliance in medication. | — |
Countries
Netherlands
Outcome results
None listed