Back to resultsEvaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients (EDVIN)
Primary Purpose
Cardiovascular Diseases, Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
iATROS
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring eHealth, cardiology, atrial fibrillation
Eligibility 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
Sites / Locations
- Internistisches Zentrum EbersbergRecruiting
- Isar Herz Zentrum, ISAR KlinikumRecruiting
- Klinikum rechts der Isar of the Technical University of MunichRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Digital eHealth platform with connected mobile 1-lead ECGs + Standard of Care
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05375877
Brief Title
Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
Acronym
EDVIN
Official Title
Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iATROS GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Atrial Fibrillation
Keywords
eHealth, cardiology, atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multicenter, longitudinal study with event-based design
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital eHealth platform with connected mobile 1-lead ECGs + Standard of Care
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
iATROS
Intervention Description
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 Measure Information:
Title
Superiority of the iATROS platform as compared to the standard of care
Description
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
Other Pre-specified Outcome Measures:
Title
Patient adherence
Description
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
Title
Disease progression
Description
Measurement of blood pressure level progression for hypertensive patients in mmHg
Time Frame
12 months to a maximum of 24 months
Title
EHRA-Score
Description
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
Title
Usage of iATROS platform
Description
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
Title
Health services usage
Description
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
Title
Disease progression
Description
Number and type of newly diagnosed diseases, with and without cardiovascular cause
Time Frame
12 months to a maximum of 24 months
Title
Assessment of hsTropI levels
Description
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
Title
CHA2-DS2-VASc-Score
Description
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
Title
HASBLED-Score
Description
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
Title
NYHA-classification
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Weyh
Phone
+49 176 856 23 142
Email
paul.weyh@i-atros.com
First Name & Middle Initial & Last Name or Official Title & Degree
Georges von Degenfeld, Dr. med.
Phone
+49 89 - 95879243
Email
georges.degenfeld@i-atros.com
Facility Information:
Facility Name
Internistisches Zentrum Ebersberg
City
Ebersberg
State/Province
Bavaria
ZIP/Postal Code
85560
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Greif, PD Dr. med.
Facility Name
Isar Herz Zentrum, ISAR Klinikum
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80331
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerd Bürkle, Dr. med.
Facility Name
Klinikum rechts der Isar of the Technical University of Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eimo Martens, Dr. med.
Email
eimo.martens@mri.tum.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
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