the Dutch-GERAF Study

Last updated: February 19, 2024
Sponsor: Dijklander Ziekenhuis
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dysrhythmia

Chest Pain

Arrhythmia

Treatment

HeartSDK

Clinical Study ID

NCT05337202
WB 694
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

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 thePPG based smartphone AF detection algorithm.

Study Design

Total Participants: 1075
Treatment Group(s): 1
Primary Treatment: HeartSDK
Phase:
Study Start date:
January 25, 2021
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Rijnstate

    Arnhem, Gelderland 6815 AD
    Netherlands

    Site Not Available

  • Dijklander Ziekenhuis

    Hoorn, Noord-Holland 1624NP
    Netherlands

    Site Not Available

  • Noordwest ziekenhuisgroep

    Alkmaar, 1815 JD
    Netherlands

    Site Not Available

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ
    Netherlands

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC
    Netherlands

    Site Not Available

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT
    Netherlands

    Site Not Available

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