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

Phase

N/A

Condition

Arrhythmia

Chest Pain

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT05375877

Ages 18-89
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 atrialfibrillation.

Exclusion

Exclusion Criteria:

< 18 years
No use of a smartphone
Lack of the physical and mental abilities necessary to use the iATROS app, or to useso-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

Study Design

February 03, 2022

July 31, 2024

Study 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.

Connect with a study center

Internistisches Zentrum Ebersberg
Ebersberg, Bavaria 85560
Germany
Active - Recruiting
Isar Herz Zentrum, ISAR Klinikum
Munich, Bavaria 80331
Germany
Active - Recruiting
Klinikum rechts der Isar of the Technical University of Munich
Munich, Bavaria 81675
Germany
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.