Observational Active not recruiting
NCT05337202 on ClinicalTrials.gov
the Dutch-GERAF Study
Official title: The Dutch Multicentre Study Into Opportunistically Screening Geriatric Patients for Atrial Fibrillation Using a PPG Smartphone App; the Dutch-GERAF Study
- Sponsor: Dijklander Ziekenhuis
- Enrollment: 1075 (Actual)
- Study start: 2021-01-25 (Actual)
- Primary completion: 2022-10-26 (Actual)
- Study completion: 2026-06-30 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
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.
Conditions
- Atrial Fibrillation
- Frailty
- Major Bleed
Intervention / Treatment
- Device: HeartSDK
Primary Outcome Measures
-
Newly identified cases of atrial fibrillation
(The first 6 months after recruitment for the study)
PPG or ECG detected new cases of atrial fibrillation
Countries
Netherlands
Locations and Investigators
- Rijnstate, Arnhem, Netherlands
- Dijklander Ziekenhuis, Hoorn, Netherlands
- Noordwest ziekenhuisgroep, Alkmaar, Netherlands
- Meander Medisch Centrum, Amersfoort, Netherlands
- Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands
- Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands
Study Officials
- René Jansen, PhD (Principal Investigator) — Northwest Hospital