Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
EDVIN
1 other identifier
interventional
270
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started Feb 2022
Typical duration for not_applicable cardiovascular-diseases
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2022
CompletedFirst Submitted
Initial submission to the registry
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedApril 21, 2023
April 1, 2023
2 years
February 14, 2022
April 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (10)
Patient adherence
12 months to a maximum of 24 months
Disease progression
12 months to a maximum of 24 months
EHRA-Score
Baseline and study completion, an average of 1 year
- +7 more other outcomes
Study Arms (1)
Digital eHealth platform with connected mobile 1-lead ECGs + Standard of Care
OTHERPatients 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- ≥ 18 years
- Diagnosis of atrial fibrillation according to ICD-10 I48.0, I48.1, I48.2, or I48.9.
- 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.
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iATROS GmbHlead
Study Sites (3)
Internistisches Zentrum Ebersberg
Ebersberg, Bavaria, 85560, Germany
Isar Herz Zentrum, ISAR Klinikum
Munich, Bavaria, 80331, Germany
Klinikum rechts der Isar of the Technical University of Munich
Munich, Bavaria, 81675, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2022
First Posted
May 17, 2022
Study Start
February 3, 2022
Primary Completion
January 31, 2024
Study Completion
July 31, 2024
Last Updated
April 21, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share