the Dutch-GERAF Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Atrial Fibrillation, Frailty, Major Bleed

Intervention / Treatment
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* Device: HeartSDK


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: HeartSDK|The photoplethysmography (PPG) application enables patients to perform a finger tip heartbeat measurement and automatic analysis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newly identified cases of atrial fibrillation | PPG or ECG detected new cases of atrial fibrillation | The first 6 months after recruitment for the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding | Major bleeding, including intra cranial haemorrhage | From recruitment until 3 years after the recruitment of the last participant | 
| Stroke | Stroke | From recruitment until 3 years after the recruitment of the last participant | 
| Death | Death | From recruitment until 3 years after the recruitment of the last participant | 
| Cognitive disorder | Development of dementia, categorized by aetiology, during follow up | From recruitment until 3 years after the recruitment of the last participant | 
| New Atrial Fibrillation, developed after the screening period | New Atrial Fibrillation, developed after the screening period | From recruitment until 3 years after the recruitment of the last participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Frailty, Major Bleed, Intra cranial Haemorrhage, Cognitive disorder, eHealth