Skip to main content
Clinical Trials/NCT05337202
NCT05337202
Active, not recruiting
Not Applicable

The Dutch Multicentre Study Into Opportunistically Screening Geriatric Patients for Atrial Fibrillation Using a PPG Smartphone App; the Dutch-GERAF Study

Dijklander Ziekenhuis6 sites in 1 country1,075 target enrollmentJanuary 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Dijklander Ziekenhuis
Enrollment
1075
Locations
6
Primary Endpoint
Newly identified cases of atrial fibrillation
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

Geriatric patients are at high risk of cardiovascular complications, and for the development of atrial fibrillation. Often atrial fibrillation exists in these patients without specific symptoms, and could therefore remain unknown. Furthermore, concerns exist about the bleeding profile of anticoagulation in the very elderly or frail patients.

This study applies opportunistic screening for atrial fibrillation as advised in the latest ESC Guideline on the diagnosis and management of atrial fibrillation. Furthermore, multiple bleeding risk scores will be applies, to better assess the bleeding risk in very elderly or frail patients.

Registry
clinicaltrials.gov
Start Date
January 25, 2021
End Date
June 30, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dijklander Ziekenhuis
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All newly referred patients of 65 years and older that visit geriatric outpatient services are eligible (including Fall clinic, Memory clinic, Pre-operative geriatric assessment clinic, or any other geriatric outpatient clinics that are led by a geriatrician).

Exclusion Criteria

  • The patient has a pacemaker or implantable cardioverter defibrillator.
  • The patient is known with a severe dementia, MoCA ≤ 15 points.
  • The patient has a severe tremor, from whatever cause, and thus is unable to use the PPG based smartphone AF detection algorithm.

Outcomes

Primary Outcomes

Newly identified cases of atrial fibrillation

Time Frame: The first 6 months after recruitment for the study

PPG or ECG detected new cases of atrial fibrillation

Secondary Outcomes

  • Major bleeding(From recruitment until 3 years after the recruitment of the last participant)
  • Stroke(From recruitment until 3 years after the recruitment of the last participant)
  • Death(From recruitment until 3 years after the recruitment of the last participant)
  • Cognitive disorder(From recruitment until 3 years after the recruitment of the last participant)
  • New Atrial Fibrillation, developed after the screening period(From recruitment until 3 years after the recruitment of the last participant)

Study Sites (6)

Loading locations...

Similar Trials