RecruitingNot ApplicableNCT07684053

Digital Screening for Atrial Fibrillation to Prevent Stroke

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

Sponsor

Medical University Innsbruck

Enrollment

100,060 participants

Start Date

Jun 29, 2026

Study Type

INTERVENTIONAL

Conditions

Stroke Atrial Fibrillation (Prevention of Stroke)

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Smartphone-based digital atrial fibrillation screening and management pathway for people with atrial fibrillation (prevention of stroke) and stroke. The study is currently recruiting participants at 1 location. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESmartphone-based digital atrial fibrillation screening and management pathway

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.