Status:
UNKNOWN
Evaluation of a Digital Care System in the Follow-Up Care of Atrial Fibrillation Patients
Lead Sponsor:
iATROS GmbH
Conditions:
Cardiovascular Diseases
Atrial Fibrillation
Eligibility:
All Genders
18-89 years
Phase:
NA
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 co...
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 pla...
Eligibility Criteria
Inclusion
- ≥ 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
- \< 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
Key Trial Info
Start Date :
February 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT05375877
Start Date
February 3 2022
End Date
July 31 2024
Last Update
April 21 2023
Active Locations (3)
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1
Internistisches Zentrum Ebersberg
Ebersberg, Bavaria, Germany, 85560
2
Isar Herz Zentrum, ISAR Klinikum
Munich, Bavaria, Germany, 80331
3
Klinikum rechts der Isar of the Technical University of Munich
Munich, Bavaria, Germany, 81675