Digital Screening for Atrial Fibrillation to Prevent Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smartphone-based digital atrial fibrillation screening and management pathway.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (Prevention of Stroke), Stroke. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study
Overview
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.
Detailed description
Atrial fibrillation is common in older adults, often remains undetected, and is a major risk factor for stroke, heart failure, hospitalization, and death. Digital screening using smartphone-based photoplethysmography provides substantial benefits in detecting atrial fibrillation compared to usual care, but it remains unclear whether such screening improves clinical outcomes.
The Austrian Digital Heart Study tests a brand-independent digital atrial fibrillation screening and management pathway embedded in the Austrian public health-care system. Participants randomized to the intervention arm use the 'Pulskontrolle' smartphone application for repeated photoplethysmographic pulse-wave (PPG) recordings. If atrial fibrillation is suspected, confirmatory 7-day ECG patch monitoring is initiated. Participants with positive PPG receive structured digital information, telehealth support, and guideline-oriented management recommendations.
The control arm receives usual care without active app-based atrial fibrillation screening. The primary endpoint is hospitalization for stroke of any type within 48 months after randomization. Secondary outcomes include mortality, cardiovascular morbidity, bleeding, atrial fibrillation-related outcomes, health-care utilization, and health-economic endpoints.
Interventions
- Device Smartphone-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, adhe
Primary outcome measures
- Hospitalization for stroke of any type (ischemic or hemorrhagic) [Time frame: Up to 48 months]
Secondary outcome measures (9)
- Hospitalization for Ischemic stroke [Time frame: Up to 48 months]
- Hospitalization for Hemorrhagic stroke [Time frame: Up to 48 months]
- All-cause mortality [Time frame: Up to 48 months]
- Cardiovascular mortality [Time frame: Up to 48 months]
- Hospitalization for heart failure [Time frame: Up to 48 months]
- The combination of hospitalization for stroke, hospitalization for heart failure and cardiovascular death. [Time frame: Up to 48 months]
- Hospitalization for bleeding [Time frame: up to 48 months]
- Fatal bleeding [Time frame: up to 48 months]
- Cost and incremental cost effectiveness ratio [Time frame: Up to 48 months]
Eligibility criteria
Inclusion criteria
- Age ≥ 65 years
- Policyholder in Austria (active unique social insurance number)
- Written electronic informed consent Exclusion Criteria
a) Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
Austria · 1 center
- Department of Internal Medicine III, Medical University Innsbruck — Innsbruck
Identifiers
NCT: NCT07684053 · 1408/2025