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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05375877
Recruitment Status : Enrolling by invitation
First Posted : May 17, 2022
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Atrial Fibrillation Device: iATROS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multicenter, longitudinal study with event-based design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
Actual Study Start Date : February 3, 2022
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Digital eHealth platform with connected mobile 1-lead ECGs + Standard of Care

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.





Primary Outcome Measures :
  1. Superiority of the iATROS platform as compared to the standard of care [ Time Frame: 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.



Other Outcome Measures:
  1. Patient adherence [ Time Frame: 12 months to a maximum of 24 months ]

    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


  2. Disease progression [ Time Frame: 12 months to a maximum of 24 months ]
    Measurement of blood pressure level progression for hypertensive patients in mmHg

  3. EHRA-Score [ Time Frame: Baseline and study completion, an average of 1 year ]

    Measure of

    - EHRA-Score (European Heart Rhythym Association - Score, possible levels I to IV, with a higher level indicating a higher burden)


  4. Usage of iATROS platform [ Time Frame: 12 months to a maximum of 24 months ]
    Measurement of patient interaction with the provided eHealth solution platform (iATROS platform), with usage being defined as sessions and session length

  5. Health services usage [ Time Frame: 12 months to a maximum of 24 months ]

    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

  6. Disease progression [ Time Frame: 12 months to a maximum of 24 months ]
    Number and type of newly diagnosed diseases, with and without cardiovascular cause

  7. Assessment of hsTropI levels [ Time Frame: Baseline and study completion, an average of 1 year ]
    Assessment of heart tissue damage through measure of high sensitive TroponinI (hsTropI) laboratory assay in venous blood in pg/ml

  8. CHA2-DS2-VASc-Score [ Time Frame: Baseline and study completion, an average of 1 year ]

    Measure of

    - CHA2-DS2-VASc-Score (possible levels 0 to 9, with a higher level indicating higher risk)


  9. HASBLED-Score [ Time Frame: Baseline and study completion, an average of 1 year ]

    Measure of

    - HASBLED-Score (possible levels 0 to 9, with a higher level indicating higher risk)


  10. NYHA-classification [ Time Frame: Baseline and study completion, an average of 1 year ]

    Measure of

    - New York Heart Association-classification (possible levels class I to IV, with a higher level indicating higher burden)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years and <90 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 or ≥ 90 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05375877


Locations
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Germany
Isar Herz Zentrum, ISAR Klinikum
Munich, Bavaria, Germany, 80331
Klinikum rechts der Isar of the Technical University of Munich
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
iATROS GmbH
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Responsible Party: iATROS GmbH
ClinicalTrials.gov Identifier: NCT05375877    
Other Study ID Numbers: 01
First Posted: May 17, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by iATROS GmbH:
eHealth
cardiology
atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes