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

Cardiovascular Diseases Clinical Trial

— EDVIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05375877
• Other study ID #: 01
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2023
• Source: iATROS GmbH
• Contact: Paul Weyh
• Phone: +49 176 856 23 142
• Email: paul.weyh[@]i-atros.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: July 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
iATROS GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient adherence	Determination of patient compliance using completion rates of therapy tasks in %; Collection of data on patient adherence, disease progression, and use of the health care system	12 months to a maximum of 24 months
Other	Disease progression	Measurement of blood pressure level progression for hypertensive patients in mmHg	12 months to a maximum of 24 months
Other	EHRA-Score	Measure of; - EHRA-Score (European Heart Rhythym Association - Score, possible levels I to IV, with a higher level indicating a higher burden)	Baseline and study completion, an average of 1 year
Other	Usage of iATROS platform	Measurement of patient interaction with the provided eHealth solution platform (iATROS platform), with usage being defined as sessions and session length	12 months to a maximum of 24 months
Other	Health services usage	Number of; patient-doctor interactions; ER visits; number of in-patient stays for cardiovascular cause; number of in-patient stays for non-cardiovascular cause(s); number of out-patient visits for cardiovascular causes at the hospital and/or resident cardiologists	12 months to a maximum of 24 months
Other	Disease progression	Number and type of newly diagnosed diseases, with and without cardiovascular cause	12 months to a maximum of 24 months
Other	Assessment of hsTropI levels	Assessment of heart tissue damage through measure of high sensitive TroponinI (hsTropI) laboratory assay in venous blood in pg/ml	Baseline and study completion, an average of 1 year
Other	CHA2-DS2-VASc-Score	Measure of; - CHA2-DS2-VASc-Score (possible levels 0 to 9, with a higher level indicating higher risk)	Baseline and study completion, an average of 1 year
Other	HASBLED-Score	Measure of; - HASBLED-Score (possible levels 0 to 9, with a higher level indicating higher risk)	Baseline and study completion, an average of 1 year
Other	NYHA-classification	Measure of; - New York Heart Association-classification (possible levels class I to IV, with a higher level indicating higher burden)	Baseline and study completion, an average of 1 year
Primary	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