Cardiovascular DiseasesEDVINNCT05375877
Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
A study testing iATROS in people with Cardiovascular Diseases and Atrial Fibrillation, run by iATROS GmbH at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cardiovascular Diseases, Atrial Fibrillation
- What is being tested?
- iATROS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 3 sitesGermany
- Study dates
- 3 Feb 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- < 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Internistisches Zentrum Ebersberg
Ebersberg, Bavaria, 85560
Martin Greif, PD Dr. med.
- Recruiting
Isar Herz Zentrum, ISAR Klinikum
Munich, Bavaria, 80331
Gerd Bürkle, Dr. med.
- Recruiting
Klinikum rechts der Isar of the Technical University of Munich
Munich, Bavaria, 81675
Eimo Martens, Dr. med., eimo.martens@mri.tum.de
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Atrial Fibrillation
- Being tested
- iATROS
- Keywords
- eHealth, cardiology, atrial fibrillation
- Medical subject headings
- Cardiovascular Diseases, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iATROSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: iATROS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months to a maximum of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start3 Feb 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, longitudinal study with event-based design
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iATROS GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375877
- Sponsor's protocol ID
- 01
- Acronym
- EDVIN
- Status last verified
- Apr 2023
- First submitted
- 14 Feb 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT05375877
- Acronym / sponsor ID
- EDVIN / 01
- Conditions
- Cardiovascular Diseases, Atrial Fibrillation
- Keywords
- eHealth, cardiology, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- iATROS GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, longitudinal study with event-based design
| Arm | Type | Receives |
|---|---|---|
| Digital eHealth platform with connected mobile 1-lead ECGs + Standard of Care | Other | Device: iATROSPatients 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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.
Key exclusion criteria (14 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iATROSThe 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. | Device | Digital eHealth platform with connected mobile 1-lead ECGs + Standard of Care |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iATROS in people with Cardiovascular Diseases and Atrial Fibrillation, run by iATROS GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Weyh (+49 176 856 23 142, paul.weyh@i-atros.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of the iATROS platform as compared to the standard of care (time frame: 12 months to a maximum of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.