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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases; Atrial Fibrillation

• Registration Number: NCT05375877
• Lead Sponsor: iATROS GmbH

Brief 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.

Study Timeline

• Study Start: 2022-02-03
• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21
• Primary Completion: 2024-01-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Superiority of the iATROS platform as compared to the standard of care	12 months to a maximum of 24 months	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.

Trial Locations

Locations (3)

Internistisches Zentrum Ebersberg; 🇩🇪 Ebersberg, Bavaria, Germany

Isar Herz Zentrum, ISAR Klinikum; 🇩🇪 Munich, Bavaria, Germany

Klinikum rechts der Isar of the Technical University of Munich; 🇩🇪 Munich, Bavaria, Germany