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Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Age ≥ 65 years

• Policyholder in Austria (active unique social insurance number)

Locations
Other Locations
Austria
Department of Internal Medicine III, Medical University Innsbruck
RECRUITING
Innsbruck
Contact Information
Primary
Sebastian J Reinstadler, MD, PhD
sebastian-johannes.reinstadler@i-med.ac.at
+4351250425621
Backup
Michael Schreinlechner, MD
Michael.Schreinlechner@i-med.ac.at
Time Frame
Start Date: 2026-06-29
Estimated Completion Date: 2032-06-01
Participants
Target number of participants: 100060
Treatments
Experimental: Digital atrial fibrillation screening and management
Participants assigned to the experimental arm are offered access to the 'Pulskontrolle' app. The app supports smartphone-camera photoplethysmography recordings for atrial fibrillation screening, digital education, and atrial fibrillation management support. Participants with suspected atrial fibrillation undergo confirmatory 7-day ECG patch monitoring. Confirmed atrial fibrillation triggers structured digital and telehealth-supported guidance according to guideline-oriented care pathways.
No_intervention: Usual care
Participants assigned to the control arm receive usual care.
Related Therapeutic Areas
Sponsors
Collaborators: UMIT Tirol, AIT Austrian Institute of Technology GmbH, Medical University of Graz
Leads: Medical University Innsbruck

This content was sourced from clinicaltrials.gov