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Digital Screening for Atrial Fibrillation to Prevent Stroke

NCT07684053 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100060

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (Prevention of Stroke)
  • Stroke

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, 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.

Sponsors & Collaborators

  • AIT Austrian Institute of Technology GmbH

    collaborator OTHER

  • Medical University of Graz

    collaborator OTHER

  • UMIT Tirol

    collaborator UNKNOWN

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Axel Bauer · Medical University Innsbruck

  • Sebastian J Reinstadler, MD, PhD · Medical University Innsbruck

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-29
Primary Completion
2031-12-31
Completion
2032-06-01

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684053 on ClinicalTrials.gov