NCT05375877

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: iATROS GmbH · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cardiovascular Diseases
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	iATROS	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.

Timeline

• Start date: 2022-02-03
• Primary completion: 2024-01-31
• Completion: 2024-07-31
• First posted: 2022-05-17
• Last updated: 2023-04-21

Locations

3 sites across 1 country: Germany