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the Dutch-GERAF Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05337202
Acronym
GERAF
Enrollment
1075
Registered
2022-04-20
Start date
2021-01-25
Completion date
2026-06-30
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Frailty, Major Bleed

Keywords

Atrial Fibrillation, Frailty, Major Bleed, Intra cranial Haemorrhage, Cognitive disorder, eHealth

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.

Interventions

DEVICEHeartSDK

The photoplethysmography (PPG) application enables patients to perform a finger tip heartbeat measurement and automatic analysis

Sponsors

Dijklander Ziekenhuis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Newly identified cases of atrial fibrillationThe first 6 months after recruitment for the studyPPG or ECG detected new cases of atrial fibrillation

Secondary

MeasureTime frameDescription
Major bleedingFrom recruitment until 3 years after the recruitment of the last participantMajor bleeding, including intra cranial haemorrhage
StrokeFrom recruitment until 3 years after the recruitment of the last participantStroke
DeathFrom recruitment until 3 years after the recruitment of the last participantDeath
Cognitive disorderFrom recruitment until 3 years after the recruitment of the last participantDevelopment of dementia, categorized by aetiology, during follow up
New Atrial Fibrillation, developed after the screening periodFrom recruitment until 3 years after the recruitment of the last participantNew Atrial Fibrillation, developed after the screening period

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026