Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1019 participants
INTERVENTIONAL
2019-10-22
2024-01-18
Brief Summary
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The only difference between the two groups will be, that patients in the app group will be informed by their local PI, if the recordings of the app indicate AF (and obtain a 14 day Holter ECG for AF verification), whereas the patients in the "usual care" group will obtain the read out of the app at the end of the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
TRIPLE
Study Groups
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App Group
In the app group, if an episode of arrhythmia is detected with the app, the local investigator will contact the respective patient to schedule an appointment for a 14 day Holter ECG.
App measurement
App measurement twice a day in the first two weeks after enrollment and twice a week (on different days) from the third week onward and whenever patients feel palpitations
14 day Holter ECG
14 day moblie patch Holter ECG for AF confirmation
Standard Care Group
The control group will perform the same measurements as the intervention group, with the only difference that a cumulated Portable Document Format (PDF) report is provided after 6 months instead of the immediate feedback in the app group.
App measurement
App measurement twice a day in the first two weeks after enrollment and twice a week (on different days) from the third week onward and whenever patients feel palpitations
Interventions
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App measurement
App measurement twice a day in the first two weeks after enrollment and twice a week (on different days) from the third week onward and whenever patients feel palpitations
14 day Holter ECG
14 day moblie patch Holter ECG for AF confirmation
Eligibility Criteria
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Inclusion Criteria
* CHA2DS2-VASc score of 3 and above, if patients are aged under 65 years
* CHA2DS2-VASc score of 2 and above, if patients are aged 65 years or older
Exclusion Criteria
* current anticoagulation treatment,
* cardiac implanted electronic device (ICD or/and PM)
* app cannot be installed due to technical problems (smartphone type, reduced smartphone storage capacity, other)
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* enrollment of the investigator, his/her family members, employees and other dependent persons
ALL
No
Sponsors
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European Union
OTHER
Preventicus GmbH
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Jens Eckstein, MD, PhD
Role: STUDY_DIRECTOR
University Hospital, Basel, Switzerland
Locations
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University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Ambulantes Herz-Kreislauf-Zentrum
Pasewalk, , Germany
Asklepeion Hospital
Athens, Attica, Greece
Semmelweis University - Heart and Vascular Center
Budapest, , Hungary
University Maastricht Polikliniek Hart+Vaat Centrum
Maastricht, Limburg, Netherlands
Jagiellonian University Medical College
Krakow, Lesser Poland Voivodeship, Poland
Universitiy Hospital Basel
Basel, Canton of Basel-City, Switzerland
Countries
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Other Identifiers
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2019-00908
Identifier Type: -
Identifier Source: org_study_id
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