Health TrialsbyHealthPanel

Digital Screening for Atrial Fibrillation to Prevent Stroke

ConditionsAtrial Fibrillation (Prevention of Stroke)Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMedical University Innsbruck

About this trial

The Austrian Digital Heart Study is a population-based, siteless, randomized, controlled digital trial testing whether a smartphone-based atrial fibrillation screening and management pathway reduces stroke hospitalizations compared with usual care. Adults aged 65 years or older in Austria are randomized to either a digital intervention using the 'Pulskontrolle' app or to usual care. The intervention includes smartphone-camera photoplethysmography for atrial fibrillation screening, confirmatory 7-day ECG patch monitoring in case of suspected atrial fibrillation, and digital education and management support. The primary outcome is hospitalization for stroke of any type within 48 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 65 years

Policyholder in Austria (active unique social insurance number)

Written electronic informed consent

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smartphone-based digital atrial fibrillation screening and management pathway

    Device

    Participants randomized to the digital intervention arm receive access to a smartphone-based atrial fibrillation screening and management pathway. The intervention includes photoplethysmography-based pulse wave measurements using a CE-certified smartphone application, followed by confirmatory 7-day ECG patch monitoring in participants with abnormal findings suggestive of atrial fibrillation. Participants with suspected or confirmed atrial fibrillation receive structured digital information, adherence support, and the option of telehealth guidance to facilitate guideline-oriented care. Treatment decisions remain the responsibility of the participant's usual treating physician.

Treatment groups

100,060 Participants
are divided into 2 treatment groups
Group A: Digital atrial fibrillation screening and managementExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hospitalization for stroke of any type (ischemic or hemorrhagic)

Time frame
Up to 48 months

Secondary outcomes

1

Hospitalization for Ischemic stroke

Time frame
Up to 48 months
2

Hospitalization for Hemorrhagic stroke

Time frame
Up to 48 months
3

All-cause mortality

Time frame
Up to 48 months
4

Cardiovascular mortality

Time frame
Up to 48 months

Other outcomes

Sponsors and contacts

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Medical University Innsbruck

Lead sponsor

AIT Austrian Institute of Technology GmbH

Collaborator

Medical University of Graz

Collaborator

UMIT Tirol

Collaborator

Source ClinicalTrials.gov
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