An interventional study of iATROS in Cardiovascular Diseases and Atrial Fibrillation, sponsored by iATROS GmbH. Status unknown at 3 sites in Germany. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by iATROS GmbH · Not applicable, Interventional, and Treatment
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.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's planned enrollment of 270 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →iATROS GmbH is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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.
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.
Time frame: 12 months to a maximum of 24 months
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
Time frame: 12 months to a maximum of 24 months
Disease progression
Measurement of blood pressure level progression for hypertensive patients in mmHg
Time frame: 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)
Time frame: 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
Time frame: 12 months to a maximum of 24 months
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
Time frame: 12 months to a maximum of 24 months
Disease progression
Number and type of newly diagnosed diseases, with and without cardiovascular cause
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Jan 2024, 23 months after the start.
Of 116 industry-sponsored interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's planned 23 months is below that.
Counting every sponsor, half of 1,148 studies reached it within 26 months; a quarter within 13 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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iATROS GmbH