Improving outcomes of AF ablation by integrated personalized lifestyle interventions: rationale and design of the prevention to improve outcomes of PVI (POP) trial

Progression of atrial fibrillation (AF) and outcomes of ablation therapy are strongly affected by modifiable risk factors. Although previous studies show beneficial effects of modifying single risk factors, there is lack of evidence from randomized controlled trials on the effects of integrated AF lifestyle programmes. The POP trial is designed to evaluate the clinical outcomes of a dedicated nurse-led AF lifestyle outpatient clinic in patients with symptomatic AF. This study is a prospective, 1:1 randomized, single centre, investigator-initiated clinical trial in 150 patients with paroxysmal or persistent AF referred for a first pulmonary vein isolation (PVI). Prior to the ablation, patients in the intervention group receive a personalized risk factor treatment programme in a specialized, protocolized, nurse-led outpatient clinic. Patient education and durable lifestyle management is promoted with an e-health platform. Patients in the control group receive standard care by cardiologists before ablation. The primary endpoint is the number of hospitalizations for re-ablation and cardioversion, with a follow-up of 12 months after ablation. Secondary endpoints include mortality, number of acute ischemic events, stroke or hospitalizations for heart failure, quality of life, number of ablations cancelled because of symptom reduction, and ablation success rate at 12 months. Determinants of patient and staff experience are explored and a cost-effectiveness analysis is included. The POP trial will help ascertain the efficacy and cost-effectiveness of an integrated technology-supported lifestyle therapy in patients with symptomatic AF. The trial is funded by the Netherlands Organisation for Health Research and Development [10070012010001]. Home sleep apnoea testing devices were provided by Itamar Medical, Ltd. [Graphics] .

Automated summary

Modifiable risk factors have a strong impact on the progression of atrial fibrillation (AF) and outcomes of ablation therapy. The POP trial aims to evaluate the effects of a dedicated nurse-led AF lifestyle outpatient clinic on clinical outcomes in patients with symptomatic AF. This randomized controlled trial will assess the efficacy and cost-effectiveness of an integrated technology-supported lifestyle therapy in AF patients. The trial is funded by the Netherlands Organisation for Health Research and Development and uses home sleep apnea testing devices provided by Itamar Medical, Ltd.