Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients

Study Overview
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Brief Summary
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The present study aims to investigate whether care improvement in patients after catheter ablation/cardioversion compared with standard care can be realized by using a digital eHealth platform with connected mobile sensors through early detection of atrial fibrillation recurrence and patient empowerment.

Detailed Description
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The main objective of the study is to compare the reliability of detection of atrial fibrillation of 2 measurement methods or protocols in terms of earliest possible detection: (1) digital eHealth platform with tethered 1-lead ECGs vs (2) standard-of-care long-term ECG. In addition, the quality of the acquired ECGs with both protocols will be compared by physician reporting based on the number of false positive abnormal findings as well as possible effects of using different mobile 1-lead ECGs. Secondary goals are the collection of data on patient adherence (e.g., reliability of performing recommended actions such as measuring ECGs, blood pressure and body weight, and taking medications), on the course of the disease, and on the use of the health care system.

Official Title
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Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients

Conditions
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Cardiovascular Diseases, Atrial Fibrillation

Intervention / Treatment
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* Device: iATROS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years Diagnosis of atrial fibrillation according to ICD-10 I48.0, I48.1, I48.2, or I48.9. Catheter ablation or cardioversion no more than 72 hours ago at the time of inclusion. Possession and use of a smartphone that allows installation and use of the iATROS app. Possession of the physical and mental abilities to use and apply the iATROS app. Patients undergoing ablation or cardioversion after a confirmed diagnosis of atrial fibrillation. Exclusion Criteria: < 18 years No use of a smartphone Lack of the physical and mental abilities necessary to use the iATROS app, or to use so-called apps on a smartphone or tablet computer in general Absolute contraindications: Tumor disease immunosuppression Dementia in an advanced stage Any disease associated with a reduced life expectancy of less than 1 year Any disease/condition that restricts participation in the study Pregnant or breastfeeding patients Participation in another clinical trial Addictive diseases Stroke in the last 3 months Transient ischemic attack (TIA) in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multicenter, longitudinal study with event-based design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Digital eHealth platform with connected mobile 1-lead ECGs + Standard of Care<br>Patients will be fitted with a 1-channel ECG monitor after inclusion in the study and discharged to post ablation care. Here, ECGs are recorded regularly until the occurrence of an arrhythmic event. After the occurrence of an event, a discussion with the investigator will be performed. Interim medical contacts will be limited to the agreed-upon follow-up appointments for the long-term ECGs and other appointments routinely scheduled in the patient's care according to the Standard of Care. long-term ECGs at defined time points | Device: iATROS<br>* The digital eHealth platform of iATROS in combination with a wearable will be used independently by the subjects of the study. In particular, the reminder function is used to remind patients to record their ECGs, take medication and perform other tasks they may have created themselves, or to use other iATROS functions, such as teleconsultation or remote medical data reporting. Furthermore, the designed training program for atrial fibrillation patients teaches them how to deal with their own disease. If unhealthy or dangerous vital signs are detected during the use of these medical devices over a longer period of time, the patient receives feedback through the application for medical presentation. This includes the detection of atrial fibrillation recurrences.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority of the iATROS platform as compared to the standard of care | Assessment of atrial fibrillation recurrences and attribution to detection system. Clinically relevant superiority of one system over the other is defined at an allocation of ≥75% of all arrhythmic events to either system. | 12 months to a maximum of 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eHealth, cardiology, atrial fibrillation