Clinical trial NCT05375877: Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
Official title: Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Atrial Fibrillation
Keywords: eHealth
cardiology
atrial fibrillation
Lead sponsor: iATROS GmbH
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, longitudinal study with event-based design
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Superiority of the iATROS platform as compared to the standard of care
timeFrame: 12 months to a maximum of 24 months
Secondary outcomes:
Other outcomes:
measure: Patient adherence
timeFrame: 12 months to a maximum of 24 months
measure: Disease progression
timeFrame: 12 months to a maximum of 24 months
measure: EHRA-Score
timeFrame: Baseline and study completion, an average of 1 year
measure: Usage of iATROS platform
timeFrame: 12 months to a maximum of 24 months
measure: Health services usage
timeFrame: 12 months to a maximum of 24 months
measure: Disease progression
timeFrame: 12 months to a maximum of 24 months
measure: Assessment of hsTropI levels
timeFrame: Baseline and study completion, an average of 1 year
measure: CHA2-DS2-VASc-Score
timeFrame: Baseline and study completion, an average of 1 year
measure: HASBLED-Score
timeFrame: Baseline and study completion, an average of 1 year
measure: NYHA-classification
timeFrame: Baseline and study completion, an average of 1 year
Locations:
city: Ebersberg
country: Germany
facility: Internistisches Zentrum Ebersberg
state: Bavaria
city: Munich
country: Germany
facility: Isar Herz Zentrum, ISAR Klinikum
state: Bavaria
city: Munich
country: Germany
facility: Klinikum rechts der Isar of the Technical University of Munich
state: Bavaria
Study officials:
References: