Digital Screening for Atrial Fibrillation to Prevent Stroke

NCT07684053 | Recruiting DMC

• 1 other identifier: 1408/2025
• Study Type: interventional
• Target: 100,060
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Digital Health; Atrial Fibrillation Screening; Photoplethysmography; Smartphone; ECG Patch; Stroke Prevention; Randomized Controlled Trial; Siteless Trial; Telehealth

Outcome Measures

Primary Outcomes (1)

• Hospitalization for stroke of any type (ischemic or hemorrhagic)

  Up to 48 months

Secondary Outcomes (9)

• Hospitalization for Ischemic stroke

  Up to 48 months

• Hospitalization for Hemorrhagic stroke

  Up to 48 months

• All-cause mortality

  Up to 48 months

• Cardiovascular mortality

  Up to 48 months

• Hospitalization for heart failure

  Up to 48 months

Study Arms (2)

Digital atrial fibrillation screening and management

EXPERIMENTAL

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.

Device: Smartphone-based digital atrial fibrillation screening and management pathway

Usual care

NO INTERVENTION

Participants assigned to the control arm receive usual care.

Interventions

Smartphone-based digital atrial fibrillation screening and management pathway DEVICE

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.

Digital atrial fibrillation screening and management

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Policyholder in Austria (active unique social insurance number)

You may not qualify if:

• a) Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Medical University of Graz: collaborator
• UMIT Tirol: collaborator
• AIT Austrian Institute of Technology GmbH: collaborator

Study Sites (1)

Department of Internal Medicine III, Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Axel Bauer

  Medical University Innsbruck

  STUDY CHAIR

• Sebastian J Reinstadler, MD, PhD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian J Reinstadler, MD, PhD

CONTACT

+4351250425621; sebastian-johannes.reinstadler@i-med.ac.at

Michael Schreinlechner, MD

CONTACT

Michael.Schreinlechner@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): June 1, 2032
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

AU (1)