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

iATROS

Status: Enrolling

Conditions: Atrial Fibrillation; Cardiovascular Diseases

Treatments: Device: iATROS

Study type: Interventional

Funder types: Industry

Identifiers

NCT05375877

01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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270 participants in 1 patient group

Digital eHealth platform with connected mobile 1-lead ECGs + Standard of Care

Other group

Description:

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

Treatment:

Device: iATROS