NCT05148338

Prevention to Improve Outcomes After PVI

The Effectivity of Lifestyle Interventions and Prevention in Patients With Atrial Fibrillation Referred for Ablation; a Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Catharina Ziekenhuis Eindhoven · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia and has a rising prevalence due to an aging population. AF increases the patient's risk of hospitalization, heart failure and stroke and results into deterioration of quality of life. Treatment of symptomatic AF consists of either antiarrhythmic medication or a pulmonary vein isolation (PVI) catheter ablation. However, lots of patients experience recurrence of AF in the first year after PVI. Previous studies showed that PVI outcomes depend on the presence of different treatable risk factors that influence the substrate for AF. Those risk factors include obesity, hypertension, cholesterol, diabetes mellitus, alcohol use, smoking and obstructive sleep apnea syndrome. However, research into the effect of treatment of those risk factors mainly consists of observational studies. Currently, it is not clear to what extent patients will benefit from comprehensive risk factor treatment prior to PVI in terms of ablation success and quality of life. The aim of the current randomized controlled trial is to determine the effect of a nurse-led, technology-supported, personalized care pathway on hospital admissions for cardioversions and re-ablation in patients with AF that are referred for ablation. Patients included in this study will be randomized to either the intervention group receiving the comprehensive risk treatment before PVI or the control group receiving standard usual care. Patients in the intervention group will visit the specialized AF nurse outpatient clinic and receive a personalized treatment plan (with a maximal duration of 6 months) including lifestyle interventions and medication. This includes sleep apnea screening with a Home Sleep Apnea Test (WatchPAT). Patients will also use the VitalHealth Engage platform. The digital platform can be used at home to report AF complaints, send home measurement and complete questionnaires. Furthermore, it supports the nurse in administering effective lifestyle changes by offering the patient personalized content and education. Both study groups will be followed up to 12 months after ablation, during which hospital admissions for cardioversion and re-ablation are evaluated. At baseline, AFEQT, EQ5D and TBQ quality of life questionnaires will be performed. The questionnaires will be repeated prior to ablation, at 3 and 12 months after ablation. At baseline, pre-ablation and after 12 months laboratory tests (such as cholesterol) will be performed to evaluate adherence to lifestyle interventions.

Conditions

• Atrial Fibrillation
• Risk Reduction
• Nurse's Role

Interventions

Type	Name	Description
OTHER	Comprehensive risk factor treatment	1. Apnea screening with Home Sleep Apnea Test. Referral to sleep physician if apnea-hypopnea index (AHI) is greater than 5 2. Weight management counseling by dietician if body mass index (BMI) is above 27 kg/m2 3. Physical activity program under supervision of physiotherapist at a specialized cardiac rehabilitation centre if BMI is over 27 or if there are complaints during exercise 4. Smoking cessation at specialized outpatient clinic 5. Blood pressure control, lipid management, glycaemic control, alcohol intake reduction by specialized AF nurse 6. Motivation and education through a digital health platform
OTHER	Standard of care	Standard usual care: Treatment by cardiologist conform existing guidelines

Timeline

• Start date: 2021-12-16
• Primary completion: 2025-07-29
• Completion: 2025-07-29
• First posted: 2021-12-08
• Last updated: 2024-08-21

Locations

1 site across 1 country: Netherlands