the Dutch-GERAF Study

NCT ID: NCT05337202

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1075 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-25

Study Completion Date

2026-06-30

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.

Detailed Description

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Conditions

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Atrial Fibrillation Frailty Major Bleed

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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HeartSDK

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

Intervention Type DEVICE

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dijklander Ziekenhuis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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René Jansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwest Hospital

Locations

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Rijnstate

Arnhem, Gelderland, Netherlands

Site Status

Dijklander Ziekenhuis

Hoorn, North Holland, Netherlands

Site Status

Noordwest ziekenhuisgroep

Alkmaar, , Netherlands

Site Status

Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Site Status

Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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Zwart LAR, Germans T, Simsek S, Ruiter JH, Jansen RWMM. Atrial fibrillation, anticoagulation and major bleeding in geriatric patients at risk of falling. OBM Geriatrics 2019, Volume 3, Issue 3, doi:10.21926/obm.geriatr.1903071

Reference Type BACKGROUND

Mol D, Riezebos RK, Marquering HA, Werner ME, Lobban TCA, de Jong JSSG, de Groot JR. Performance of an automated photoplethysmography-based artificial intelligence algorithm to detect atrial fibrillation. Cardiovasc Digit Health J. 2020 Oct 22;1(2):107-110. doi: 10.1016/j.cvdhj.2020.08.004. eCollection 2020 Sep-Oct. No abstract available.

Reference Type BACKGROUND
PMID: 35265881 (View on PubMed)

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

Reference Type RESULT
PMID: 32860505 (View on PubMed)

Zwart LA, Jansen RW, Ruiter JH, Germans T, Simsek S, Hemels ME. Opportunistic screening for atrial fibrillation with a single lead device in geriatric patients. J Geriatr Cardiol. 2020 Mar;17(3):149-154. doi: 10.11909/j.issn.1671-5411.2020.03.007.

Reference Type RESULT
PMID: 32280331 (View on PubMed)

Searle SD, Mitnitski A, Gahbauer EA, Gill TM, Rockwood K. A standard procedure for creating a frailty index. BMC Geriatr. 2008 Sep 30;8:24. doi: 10.1186/1471-2318-8-24.

Reference Type RESULT
PMID: 18826625 (View on PubMed)

Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):722-7. doi: 10.1093/gerona/62.7.722.

Reference Type RESULT
PMID: 17634318 (View on PubMed)

Moraes JL, Rocha MX, Vasconcelos GG, Vasconcelos Filho JE, de Albuquerque VHC, Alexandria AR. Advances in Photopletysmography Signal Analysis for Biomedical Applications. Sensors (Basel). 2018 Jun 9;18(6):1894. doi: 10.3390/s18061894.

Reference Type RESULT
PMID: 29890749 (View on PubMed)

Dutch-GERAF investigators; Zwart LAR, Spruit JR, Hemels MEW, de Groot JR, Pisters R, Riezebos RK, Jansen RWMM. Design of the Dutch multicentre study on opportunistic screening of geriatric patients for atrial fibrillation using a smartphone PPG app: the Dutch-GERAF study. Neth Heart J. 2024 May;32(5):200-205. doi: 10.1007/s12471-024-01868-6. Epub 2024 Apr 15.

Reference Type DERIVED
PMID: 38619715 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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WB 694

Identifier Type: -

Identifier Source: org_study_id

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