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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital eHealth platform with connected mobile 1-lead ECGs + Standard of Care | Other | Patients 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iATROS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Disease progression |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Weyh | Contact | +49 176 856 23 142 | paul.weyh@i-atros.com | |
| Georges von Degenfeld, Dr. med. | Contact | +49 89 - 95879243 | georges.degenfeld@i-atros.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internistisches Zentrum Ebersberg | Recruiting | Ebersberg | Bavaria | 85560 | Germany |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospective, multicenter, longitudinal study with event-based design
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Measurement of blood pressure level progression for hypertensive patients in mmHg
| 12 months to a maximum of 24 months |
| 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 |
| 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 |
| Health services usage | Number of
| 12 months to a maximum of 24 months |
| Disease progression | Number and type of newly diagnosed diseases, with and without cardiovascular cause | 12 months to a maximum of 24 months |
| 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 |
| 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 |
| 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 |
| 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 |
| Isar Herz Zentrum, ISAR Klinikum | Recruiting | Munich | Bavaria | 80331 | Germany |
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| Klinikum rechts der Isar of the Technical University of Munich | Recruiting | Munich | Bavaria | 81675 | Germany |
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