atrial fibrillation cardiac arrhytmia
Conditions
Interventions
The investigational treatment consists of multiple outpatient clinic visits
which are conducted by a specialized nurse practitioner. The modifiable risk
factors will be assessed during the intake vi
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with paroxysmal or persistent atrial fibrillation referred for initial catheter ablation Age 18-75 years The patient should have at least on treatable risk factor (BMI >=27 kg/m2, hyperlipidaemia, hypertension, diabetes mellitus with HbA1c >=53 mmol/mol, active smoking, or excess alcohol use) Patients are willing and able to use the VitalHealth Engage platform on their own preferred device
Exclusion criteria
Exclusion criteria: Longstanding persistent atrial fibrillation (persistent atrial fibrillation for more than 1 year) Permanent atrial fibrillation Asymptomatic atrial fibrillation Prior ablation Severe valvular heart disease Prior or soon foreseen implantation of cardiac device Acute coronary syndroom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the number of cardioversions and re-ablations from patient inclusion up to 12 months after the ablation. We will also include events that occur before the ablation and within the first three months after the ablation, the so called blanking period. We expect that the proposed intervention will lead to a 30% reduction of the primary endpoint. The primary outcome is the composite of hospital admissions for cardioversion and re-ablations with a follow-up of 12 months after the index ablation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Total hospitalisations for cardioversion - Total hospitalisations for re-ablation - The composite of mortality, stroke or hospitalisation for heart failure or acute ischemic events - Total mortality - Stroke - Hospitalisation for heart failure or acute ischemic events - Success of ablation - Cancelation of index ablation - Medical costs, resource utilization, and cost-effectiveness and patient value - Quality of life - Treatment burden - Ablation procedure - Adherence to lifestyle interventions - Effect of OSA screening - Exploration of patient experience and its main determinants in the new outpatient clinic - Exploration of staff experience and its main determinants in the new outpatient clinic | — |
Countries
Netherlands
Outcome results
None listed