Endpoints
arrhythmias, heart failure, strokes
RECURRENCE, SECONDARY, EVENTS, HEART FAILURE, ARRHYTHMIAS, STROKES
The primary composite endpoint of the study is the number of hospitalizations for re-ablation and cardioversion from baseline to 12 months after ablation. The conditions for performing a re-ablation and cardioversion are explained above.Secondary endpoints are the number of hospitalizations for re-ablation, the number of cardioversions, the number of cancelled ablations because of overall symptom reduction, mortality, number of strokes, acute ischemic events, or hospitalizations for heart failure at 12 months after ablation.Further secondary endpoints include change in weight, blood pressure and laboratory tests at baseline, after the lifestyle intervention (for the intervention group) and at 1 year after ablation. Furthermore, ablation success is determined at 12 months after ablation. The ablation is considered to be successful when patients can stop their antiarrhythmic drugs after 3 months, without having recurrence of symptomatic arrhythmias urging for re-ablation. The elaborate lifestyle changes might negatively affect treatment burden. Treatment burden is the perception of cumulative work a patient has to perform to manage their health, and should, therefore, be limited. Therefore, further secondary endpoints include the change in quality of life and treatment burden from baseline to before ablation, at 3 months, and 12 months after ablation. The patient’s general quality of life will be assessed with the Dutch version of the EuroQol-5D questionnaire. This questionnaire includes 5 health-state measures and is suitable to determine quality-adjusted life-years for a cost–utility analysis [