Digital Atrial Fibrillation Screening to Prevent Stroke in Older Adults
Official title: Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study
Run by Medical University Innsbruck · NCT07684053 · Data updated 2026-11-12
Older adults in Austria will try a smartphone-based atrial fibrillation screening app to see if it reduces stroke hospitalizations compared with usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 100060 (estimated) |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 1 site (Innsbruck, Tyrol) |
| Status | Recruiting |
| Started | June 29, 2026 |
| Main results expected | December 31, 2031 |
| Study ends | June 1, 2032 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07684053 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 65 years or older who are policyholders in Austria and not on oral anticoagulation and without a cardiac implanted electronic device.
✕Probably not a fit
Patients without detectable atrial fibrillation during screening or who are already anticoagulated may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This population-based, siteless randomized trial tests whether a smartphone app using photoplethysmography can identify atrial fibrillation and prompt management changes to prevent strokes. Participants aged 65 and older are randomized to the digital intervention or usual care, with confirmatory 7-day ECG patch monitoring if AF is suspected. The primary outcome is hospitalization for stroke of any type within 48 months, with secondary outcomes including mortality, cardiovascular events, bleeding, and health-care utilization. The study is embedded in the Austrian public health system and uses a brand-independent AF screening pathway, with digital education and telehealth support for those in the intervention arm.
Why it matters
Potential benefit: If successful, the approach could enable earlier AF detection and potentially reduce stroke risk in older adults through timely management.
How similar studies have gone: Prior digital AF screening initiatives have shown improved detection but mixed evidence on hard outcomes like stroke; this trial tests real-world effectiveness in a national health system.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Age ≥ 65 years 2. Policyholder in Austria (active unique social insurance number) 3. Written electronic informed consent Exclusion Criteria a) Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)
Where it's running
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Department of Internal Medicine III, Medical University Innsbruck
Innsbruck, Tyrol, Austria Recruiting
Study contacts
- Principal investigator: Sebastian J Reinstadler, MD, PhD — Medical University Innsbruck
- Study coordinator: Sebastian J Reinstadler, MD, PhD
- Email: sebastian-johannes.reinstadler@i-med.ac.at
- Phone: +4351250425621
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.